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Miscellaneous
Subpart B—Biological Stains
CFR Sub-Part
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
CDN
Urease, Photometric, Urea Nitrogen
2
Product Code
CDO
Acid, Uric, Uricase (U.V.)
1
Product Code
CDP
Radioimmunoassay, Total Triiodothyronine
2
Product Code
CDE
Chromatographic Separation/Zimmerman, 17-Ketosteroids
1
Product Code
CHA
Radioimmunoassay, Corticosterone
1
Product Code
CDF
Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
1
Product Code
CDG
Chromatography Separation/Zimmerman 17-Ketogenic Steroids
1
Product Code
CDH
Acid, Uric, Phosphotungstate Reduction
1
Product Code
CDK
Acid, Vanilmandelic, Electrophoretic Separation
1
Product Code
CDL
Berthelot Indophenol, Urea Nitrogen
2
Product Code
CDM
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
1
Product Code
CCY
Zimmerman (Spectrophotometric), 17-Ketosteroids
1
Product Code
CCZ
Zimmerman/Norymberski, 17-Ketogenic Steroids
1
Product Code
CDA
Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
1
Product Code
CDB
Porter Silber Hydrazone, 17-Hydroxycorticosteroids
1
Product Code
CDC
L-Leucyl B-Naphthylamide, Leucine Aminopeptidase
1
Product Code
CDD
Radioassay, Vitamin B12
2
Product Code
CDQ
Urease And Glutamic Dehydrogenase, Urea Nitrogen
2
Product Code
CDR
1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine
1
Product Code
CDS
Electrode, Ion Specific, Urea Nitrogen
2
Product Code
CDT
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
1
Product Code
CDW
Diacetyl-Monoxime, Urea Nitrogen
2
Product Code
CDX
Radioimmunoassay, Total Thyroxine
2
Product Code
CDZ
Radioimmunoassay, Testosterones And Dihydrotestosterone
1
Product Code
CEA
Tlc Chromatographic Separation Triglycerides
1
Product Code
CEC
Radioimmunoassay, Free Thyroxine
2
Product Code
CED
5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
1
Product Code
CEE
Radioimmunoassay, Thyroxine-Binding Globulin
2
Product Code
CEF
Electrophoretic, Protein Fractionation
1
Product Code
CEI
Uranyl Acetate/Zinc Acetate, Sodium
2
Product Code
CEJ
Tetraphenyl Borate, Colorimetry, Potassium
2
Product Code
CEK
Biuret (Colorimetric), Total Protein
2
Product Code
CEL
Ammonium Molybdate And Ammonium Vanadate, Phospholipids
1
Product Code
CEM
Electrode, Ion Specific, Potassium
2
Product Code
CEN
Dye-Indicator, Ph (Urinary, Non-Quantitative)
1
Product Code
CEO
Phosphomolybdate (Colorimetric), Inorganic Phosphorus
1
Product Code
CEP
Radioimmunoassay, Luteinizing Hormone
1
Product Code
K
01
3582
MAYBE?MOM MINI OVULATION MICROSCOPE
1
Cleared 510(K)
K
02
2829
INSTANT-VIEW LH OVULATION PREDICTING TEST
1
Cleared 510(K)
K
02
1409
AT HOME OVULATION TEST, MODEL 9032
1
Cleared 510(K)
K
01
3874
CLEARPLANE EASY OVULATION TEST
1
Cleared 510(K)
K
01
3323
TCI-31 LIFELONG OVULATION TESTER
1
Cleared 510(K)
K
01
2252
QUIK-CHECK OVULATION PREDICTOR
1
Cleared 510(K)
K
01
0244
SURE CHECK OVULATION PREDICTOR
1
Cleared 510(K)
K
00
2867
INVERNESS MEDICAL OVULATION PREDICTOR TEST
1
Cleared 510(K)
K
99
1466
EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)
1
Cleared 510(K)
K
99
1386
EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)
1
Cleared 510(K)
K
99
0249
OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031
1
Cleared 510(K)
K
98
3113
BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT
1
Cleared 510(K)
K
98
1271
CLEARPLAN EASY OVULATION TEST
1
Cleared 510(K)
K
97
4508
DBEST ONE-STEP OVULATION TEST
1
Cleared 510(K)
K
97
3310
TBD* ONE-STEP OVULATION PREDICTOR TEST
1
Cleared 510(K)
K
97
0467
EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT
1
Cleared 510(K)
K
96
4982
VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)
1
Cleared 510(K)
K
96
4694
ELECSYS LH ASSAY
1
Cleared 510(K)
K
96
4925
SEALITE SCIENCES, INC. AQUALITE LH
1
Cleared 510(K)
K
96
3693
OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST
1
Cleared 510(K)
K
96
2866
OPUS HLH
1
Cleared 510(K)
K
96
2041
ACS LH2 IMMUNOASSAY
1
Cleared 510(K)
K
96
0233
MINICLINIC OVULATION PREDICTOR
1
Cleared 510(K)
K
96
1109
ACTIVE LH IRMA
1
Cleared 510(K)
K
95
3581
FIRST RESPONSE OVULATION PREDICTOR TEST
1
Cleared 510(K)
K
95
3063
CONCEIVE OVULATION PREDICTOR
1
Cleared 510(K)
K
95
1538
BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT
1
Cleared 510(K)
K
95
1748
COAT-A-COUNT LH IRMA
1
Cleared 510(K)
K
93
5319
CHEMILUMINESCENCE LH
1
Cleared 510(K)
K
94
3252
PRO-STEP LH OVULATION PREDICTION TEST
1
Cleared 510(K)
K
94
3996
DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD
1
Cleared 510(K)
K
94
3188
SEALITE SCIENCE, INC. AQUALITE(R) LH
1
Cleared 510(K)
K
94
2638
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
1
Cleared 510(K)
K
94
0549
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
1
Cleared 510(K)
K
93
5134
ONE STEP LH TEST
1
Cleared 510(K)
K
93
0306
COBAS CORE LH EIA
1
Cleared 510(K)
K
92
6394
VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
1
Cleared 510(K)
K
93
0185
OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP
1
Cleared 510(K)
K
92
2944
IMMUCHEM LH-MW ELISA
1
Cleared 510(K)
K
92
1176
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
1
Cleared 510(K)
K
92
0920
ELISA TUBE LH TEST KIT
1
Cleared 510(K)
K
92
0411
IMMULITE HLH
1
Cleared 510(K)
K
92
0160
LH GEN III SELF-TEST/CONCEIVE
1
Cleared 510(K)
K
92
0504
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
1
Cleared 510(K)
K
91
3938
OPUS(R) LH TEST SYSTEM
1
Cleared 510(K)
K
91
1050
LH IRMA IMMUNOMAG
1
Cleared 510(K)
K
91
0351
MINICLINIC OVULATION PREDICTION TEST
1
Cleared 510(K)
K
91
0717
PANTEX IRMA LH 1251 KIT
1
Cleared 510(K)
K
91
0198
CIBA CORNING ACS LH IMMUNOASSAY
1
Cleared 510(K)
K
90
4387
BIOCLONES ELEGANCE LH ELISA KIT
1
Cleared 510(K)
K
90
2786
MILENIA (TM) LH
1
Cleared 510(K)
K
90
3052
IMMUNOCORP LH IRMA COATED TUBE
1
Cleared 510(K)
K
90
2443
LUMATAG(TM) LH DIAGNOSTIC KIT
1
Cleared 510(K)
K
90
2208
MODIFIED OVUGEN
1
Cleared 510(K)
K
90
2398
CIBA CORNING MAGIC LITE LH IMMUNOASSAY
1
Cleared 510(K)
K
90
0779
ENZYMUN TEST(R) LH
1
Cleared 510(K)
K
90
0621
FIAGEN(TM) HLH.S
1
Cleared 510(K)
K
89
6866
LUTEINIZING HORMONE-EIA-XT
1
Cleared 510(K)
K
89
6642
MODIFIED LH ENZYME IMMUNOASSAY TEST KIT
1
Cleared 510(K)
K
89
5094
TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT
1
Cleared 510(K)
K
89
4579
CLEARPLAN EASY
1
Cleared 510(K)
K
89
4279
LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST
1
Cleared 510(K)
K
89
1762
MINICLINIC OVULATION PREDICTION TEST
1
Cleared 510(K)
K
89
3605
SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY
1
Cleared 510(K)
K
89
0510
ABBOTT OVULATION PREDICTOR TEST
1
Cleared 510(K)
K
88
3814
DELFIA HLH SPEC KIT
1
Cleared 510(K)
K
88
4498
COTUBE LH IRMA ASSAY
1
Cleared 510(K)
K
88
3530
FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST
1
Cleared 510(K)
K
88
4138
ABBOTT IMX LH
1
Cleared 510(K)
K
88
2340
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA
1
Cleared 510(K)
K
88
2252
PHASE II LH KIT
1
Cleared 510(K)
K
88
0933
AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST
1
Cleared 510(K)
K
88
1124
ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY
1
Cleared 510(K)
K
88
0758
SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY
1
Cleared 510(K)
K
87
4624
FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301
1
Cleared 510(K)
K
87
4032
IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5
1
Cleared 510(K)
K
87
0584
O.P.T.(TM) OVULATION PREDICTION TEST
1
Cleared 510(K)
K
87
3534
OVUGEN SURETEST
1
Cleared 510(K)
K
87
3668
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
1
Cleared 510(K)
K
87
1241
ANSWER OVULATION TEST KIT
1
Cleared 510(K)
K
87
3186
LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA
1
Cleared 510(K)
K
87
3052
STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY
1
Cleared 510(K)
K
87
2131
TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY
1
Cleared 510(K)
K
87
2727
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE
1
Cleared 510(K)
K
87
1332
CLEARPLAN
1
Cleared 510(K)
K
87
1726
OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)
1
Cleared 510(K)
K
87
1602
MICROCHECK LH OVULATION TEST
1
Cleared 510(K)
K
86
3934
DPC COAT-A-COUNT IRMA LH KIT
1
Cleared 510(K)
K
86
3442
UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE
1
Cleared 510(K)
K
86
2055
CANWEST OVU-BLUE
1
Cleared 510(K)
K
86
4144
LUTEINIZING HORMONE (LH-IRMA) RIA KIT
1
Cleared 510(K)
K
86
3929
TERUMO SENSIBEAD(TM) EIA HLH KIT
1
Cleared 510(K)
K
86
3679
ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM
1
Cleared 510(K)
K
86
1354
RIGHT-DAY OVULATION HOME TEST
1
Cleared 510(K)
K
86
0828
FORETEL, COLOR OVULATION TEST
1
Cleared 510(K)
K
86
0538
RIGHT-DAY URINARY LH (EIA)
1
Cleared 510(K)
K
86
2180
MODIFIED COTROPIN RADIOIMMUNOASSAY KIT
1
Cleared 510(K)
K
86
0984
TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT
1
Cleared 510(K)
K
86
0334
VISI-CHECK HLH TEST MONOCLONAL
1
Cleared 510(K)
K
86
0333
MICRO-ELISA HLH TEST KIT MONOCLONAL
1
Cleared 510(K)
K
86
0308
SUCROSEP LUTEINIZING HORMONE (LH) IRMA
1
Cleared 510(K)
K
85
5173
DELFIA TM HLH KIT
1
Cleared 510(K)
K
85
4838
LEE-BEAD BETA LH (EIA)
1
Cleared 510(K)
K
85
3142
OVUTIME OVULATION PREDICTOR TEST
1
Cleared 510(K)
K
85
3837
LH/FSH RADIOIMMUNOASSAY KIT
1
Cleared 510(K)
K
85
2146
QUIDEL QUEST OVULATION TEST
1
Cleared 510(K)
K
85
1445
COLOR OVULATION TEST
1
Cleared 510(K)
K
85
2376
SIMULTANEOUS LH/FSH SYSTEM BY RIA
1
Cleared 510(K)
K
85
1332
BLHI LUTEINIZING HORMONE
1
Cleared 510(K)
K
85
1104
AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT
1
Cleared 510(K)
K
85
0480
OVU STICK SELF-TEST -MODIFICATION
1
Cleared 510(K)
K
84
3284
OVUSTICK SELF-TEST
1
Cleared 510(K)
K
84
1545
ENZYME IMMUNOASSAY FOR DETECTION HORM
1
Cleared 510(K)
K
84
2445
LH RIA
1
Cleared 510(K)
K
84
0412
OVU STICK URINE HLH KIT
1
Cleared 510(K)
K
84
0188
MICROMEDIC LH & FSH RIA KIT
1
Cleared 510(K)
K
84
0174
LH QUIK RIA KIT
1
Cleared 510(K)
K
83
3854
LH RIA
1
Cleared 510(K)
K
83
3376
RIANEN LUTEINIZING HORMONE RIA KIT
1
Cleared 510(K)
K
82
3476
GAMMADAB LH RADIO-KIT #CA-1508
1
Cleared 510(K)
K
82
3380
125-I LH RADIOIMMUNOASSAY KIT
1
Cleared 510(K)
K
82
2288
LH (125I) RADIOIMMUNOASSAY
1
Cleared 510(K)
K
82
1346
QUANTIMUNE HLH RIA
1
Cleared 510(K)
K
82
0760
LH RADIOIMMUNOASSAY TEST SYSTEM
1
Cleared 510(K)
K
82
0741
MR1 LUTROPIN RIA KIT
1
Cleared 510(K)
K
82
0753
AMERLEX LH RIA KIT (CODE IM2081)
1
Cleared 510(K)
K
82
0357
LUTEINIZING HORMONE KIT
1
Cleared 510(K)
K
81
3213
SHARIA-LH RIA KIT FOR QUANTITATION HORMO
1
Cleared 510(K)
K
81
1994
RADIOIMMUNOASSAY LUTEINIZING HORMONE
1
Cleared 510(K)
K
81
1024
LUTEINIZING HORMONE DIRECT RIA KIT 125/I
1
Cleared 510(K)
K
81
0754
LUTENIZING HORMONES
1
Cleared 510(K)
K
81
0741
LUTEINIZING HORMONE
1
Cleared 510(K)
K
81
0662
LEECO LH-QUANT DIAGNOSTIC KIT
1
Cleared 510(K)
K
81
0302
QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM
1
Cleared 510(K)
K
80
3278
LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT
1
Cleared 510(K)
K
80
0106
LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS
1
Cleared 510(K)
K
79
2350
CENTRIA LH RIA
1
Cleared 510(K)
K
79
2000
LUTEINIZING HORMONE (LH) RIA
1
Cleared 510(K)
K
79
1405
125I LEUTINIZING HORMONE RIA KIT
1
Cleared 510(K)
K
78
1685
RIA KIT, LH
1
Cleared 510(K)
K
78
0576
125-I LABELED HUMAN LUTEINIZING HORMONE
1
Cleared 510(K)
K
78
0367
RIA SYS. FOR HUMAN LUTEINIZING HORMONE
1
Cleared 510(K)
K
77
0854
LUTEINIZING HORMONE RIA REAGENT, LH-RIA
1
Cleared 510(K)
CEQ
Molybdenum Blue Method, Phospholipids
1
Product Code
CER
2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase
2
Product Code
CES
Chromogenesis, Phenylketones (Urinary, Non-Quant.)
1
Product Code
CET
Olive Oil Emulsion (Turbidimetric), Lipase
1
Product Code
CEW
Radioimmunoassay, Parathyroid Hormone
2
Product Code
CEX
Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
2
Product Code
CFA
Electrode, Ion Specific, Magnesium
1
Product Code
CFB
Chromatographic Derivative, Total Lipids
1
Product Code
CFD
Sulfophosphovanillin, Colorimetry, Total Lipids
1
Product Code
CFE
Electrophoretic, Lactate Dehydrogenase Isoenzymes
2
Product Code
CFG
Oil Emulsion/Thymolphthalein (Titrimetric), Lipase
1
Product Code
CFH
Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
2
Product Code
CFJ
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
2
Product Code
CFL
Radioimmunoassay, Human Growth Hormone
1
Product Code
CFM
Bathophenanthroline, Colorimetry, Iron (Non-Heme)
1
Product Code
CFO
Titrimetric, Magnesium
1
Product Code
CFP
Radioimmunoassay, Immunoreactive Insulin
1
Product Code
CFR
Hexokinase, Glucose
2
Product Code
CFT
Radioimmunoassay, Prolactin (Lactogen)
1
Product Code
CFW
Copper Reduction, Glucose
2
Product Code
CGA
Glucose Oxidase, Glucose
2
Product Code
CGC
Radioimmunoassay, Gastrin
1
Product Code
CGD
Ferricyanide, Glucose
2
Product Code
CGE
Orthotoluidine, Glucose
2
Product Code
CGF
Radioimmunoassay, Estrone
1
Product Code
CGH
Electrophoretic, Globulin
1
Product Code
CGI
Radioimmunoassay, Estriol
1
Product Code
CGJ
Radioimmunoassay, Follicle-Stimulating Hormone
1
Product Code
CGL
Electrode, Ion Based, Enzymatic, Creatinine
2
Product Code
CGN
Acid, Folic, Radioimmunoassay
2
Product Code
CGO
Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
1
Product Code
CGR
Radioimmunoassay, Cortisol
2
Product Code
CGS
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
2
Product Code
CGT
Radioimmunoassay, Cyclic Gmp
2
Product Code
CGX
Alkaline Picrate, Colorimetry, Creatinine
2
Product Code
CGZ
Electrode, Ion-Specific, Chloride
2
Product Code
CHC
Titrimetric Permanganate And Bromophenol Blue, Calcium
2
Product Code
CHD
Acid, Ferric Ion-Sulfuric, Cholesterol
1
Product Code
CHE
Radioimmunoassay, Corticoids
1
Product Code
CHG
Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride
2
Product Code
CHH
Enzymatic Esterase--Oxidase, Cholesterol
1
Product Code
CHI
Lipase-Esterase, Enzymatic, Photometric, Lipase
1
Product Code
CHJ
Mercuric Thiocyanate, Colorimetry, Chloride
2
Product Code
CHK
Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride
2
Product Code
CHL
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
2
Product Code
CHM
Radioimmunoassay, Total Estrogens In Pregnancy
1
Product Code
CHO
Radioimmunoassay, Cyclic Amp
2
Product Code
CHP
Radioimmunoassay, Estradiol
1
Product Code
CHQ
Chromatographic/Fluorometric Method, Catecholamines
1
Product Code
CHR
Titrimetric Phenol Red, Carbon-Dioxide
2
Product Code
CHS
Coulometric Method, Carbon-Dioxide
2
Product Code
CHT
Electrophoretic Method, Catecholamines
1
Product Code
CHW
Titrimetric With Edta And Indicator, Calcium
2
Product Code
CHZ
Di (O-Hydroxyphenylimine) Ethane, Calcium
2
Product Code
CIA
Methylthymol Blue, Calcium
2
Product Code
CIB
Radioimmunoassay, Angiotensin I And Renin
2
Product Code
CIC
Cresolphthalein Complexone, Calcium
2
Product Code
CID
Alizarin Sulfonate, Calcium
2
Product Code
CIE
Volumetric/Manometric, Carbon-Dioxide
2
Product Code
CIF
Vanillin Pyruvate, Ast/Sgot
2
Product Code
CIG
Diazo Colorimetry, Bilirubin
2
Product Code
CIJ
Saccharogenic, Amylase
2
Product Code
CIK
Radial Diffusion, Amylase
2
Product Code
CIL
Cresol Red Colorimetry, Carbon-Dioxide
2
Product Code
CIN
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
2
Product Code
CIO
Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
2
Product Code
CIQ
Diazo, Ast/Sgot
2
Product Code
CIS
Hydrazone Colorimetry, Ast/Sgot
2
Product Code
CIT
Nadh Oxidation/Nad Reduction, Ast/Sgot
2
Product Code
CIW
Starch-Dye Bound Polymer, Amylase
2
Product Code
CIX
Bromcresol Green Dye-Binding, Albumin
2
Product Code
CIY
Radioimmunoassay, Androsterone
1
Product Code
CIZ
Radioimmunoassay, Androstenedione
1
Product Code
CJA
Amyloclastic, Amylase
2
Product Code
CJB
Chromatographic Separation/Radioimmunoassay, Aldosterone
2
Product Code
CJC
Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase
1
Product Code
CJD
Nitrosalicylate Reduction, Amylase
2
Product Code
CJE
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
2
Product Code
CJF
Tetrabromophenolphthalein, Albumin
2
Product Code
CJG
Tetrabromo-M-Cresolsulfonphthalein, Albumin
2
Product Code
CJH
Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes
2
Product Code
CJI
Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
2
Product Code
CJJ
Diazo, Alt/Sgpt
1
Product Code
CJK
Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes
2
Product Code
CJL
Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes
2
Product Code
CJM
Radioimmunoassay, Aldosterone
2
Product Code
CJN
Acid Phosphatase, Nitrophenylphosphate
2
Product Code
CJO
Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
2
Product Code
CJQ
Radial Immunodiffusion, Albumin
2
Product Code
CJR
Acid Phosphatase, Thymol Blue Monophosphate
2
Product Code
CJT
Hydrazone Colorimetry, Aldolase
1
Product Code
CJW
Bromcresol Purple Dye-Binding, Albumin
2
Product Code
CJX
Acid Phosphatase, Disodium Phenylphosphate
2
Product Code
CJY
Azo Dye, Calcium
2
Product Code
CJZ
Acid, Hydroxyazobenzene-Benzoic, Albumin
2
Product Code
CKA
Nadh Oxidation/Nad Reduction, Alt/Sgpt
1
Product Code
CKB
Acid Phosphatase, Naphthyl Phosphate
2
Product Code
CKC
Vanillin Pyruvate, Alt/Sgpt
1
Product Code
CKD
Hydrazone Colorimetry, Alt/Sgpt
1
Product Code
CKE
Acid Phosphatase, Thymolphthale Inmonophosphate
2
Product Code
CKF
Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
2
Product Code
CKG
Radioimmunoassay, Acth
2
Product Code
CKH
Acid Phosphatase, Beta Glycerophosphate
2
Product Code
DHA
System, Test, Human Chorionic Gonadotropin
2
Product Code
GIM
Tubes, Vacuum Sample, With Anticoagulant
2
Product Code
GJE
Tray, Blood Collection
2
Product Code
JFH
Acid Phosphatase (Prostatic), Tartrate Inhibited
2
Product Code
JFJ
Catalytic Methods, Amylase
2
Product Code
JFL
Ph Rate Measurement, Carbon-Dioxide
2
Product Code
JFM
Enzymatic Method, Bilirubin
2
Product Code
JFN
Atomic Absorption, Calcium
2
Product Code
JFO
Fluorometric, Calcium
2
Product Code
JFP
Electrode, Ion Specific, Calcium
2
Product Code
JFS
Coulometric, Chloride
2
Product Code
JFT
Fluorometric, Cortisol
2
Product Code
JFY
Enzymatic Method, Creatinine
2
Product Code
JGC
Tryptophan Measurement (Colorimetric), Globulin
1
Product Code
JGD
Nephelometric Method, Globulin
1
Product Code
JGE
Turbidimetric Method, Globulin
1
Product Code
JGF
Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
2
Product Code
JGG
L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase
1
Product Code
JGI
Atomic Absorption, Magnesium
1
Product Code
JGJ
Photometric Method, Magnesium
1
Product Code
JGK
Ferric Chloride, Phenylketones (Urinary, Non-Quant.)
1
Product Code
JGM
Flame Photometry, Potassium
2
Product Code
JGP
Lowry (Colorimetric), Total Protein
2
Product Code
JGQ
Turbidimetric, Total Protein
2
Product Code
JGR
Refractometric, Total Protein
2
Product Code
JGS
Electrode, Ion Specific, Sodium
2
Product Code
JGT
Flame Photometry, Sodium
2
Product Code
JGW
Fluorometric Method, Triglycerides
1
Product Code
JGX
Turbidimetric Method, Triglycerides
1
Product Code
JGY
Colorimetric Method, Triglycerides
1
Product Code
JGZ
O-Phthalaldehyde, Urea Nitrogen
2
Product Code
JHA
Acid, Uric, Uricase (Gasometric)
1
Product Code
JHC
Acid, Uric, Uricase (Oxygen Rate)
1
Product Code
JHD
Fluorometric Method, 17-Hydroxycorticosteroids
1
Product Code
JHE
Radioassay, 17-Hydroxycorticosteroids
1
Product Code
JHF
Colorimetric Method, Lecithin/Sphingomyelin Ratio
2
Product Code
JHG
Chromatographic Separation, Lecithin/Sphingomyelin Ratio
2
Product Code
JHH
Electrophoretic Method, Lecithin/Sphingomyelin Ratio
2
Product Code
JHI
Visual, Pregnancy Hcg, Prescription Use
2
Product Code
JHJ
Agglutination Method, Human Chorionic Gonadotropin
2
Product Code
JHL
Microdensitometry Method, Lipoproteins
1
Product Code
JHM
Colorimetric Method, Lipoproteins
1
Product Code
JHN
Turbidimetric Method, Lipoproteins
1
Product Code
JHO
Electrophoretic Separation, Lipoproteins
1
Product Code
JHP
Radial Immunodiffusion, Lipoproteins
1
Product Code
JHQ
Nephelometric Method, Lipoproteins
1
Product Code
JHS
Differential Rate Kinetic Method, Cpk Or Isoenzymes
2
Product Code
JHT
Chromatographic Separation, Cpk Isoenzymes
2
Product Code
JHW
U.V. Method, Cpk Isoenzymes
2
Product Code
JHX
Fluorometric Method, Cpk Or Isoenzymes
2
Product Code
JHY
Colorimetric Method, Cpk Or Isoenzymes
2
Product Code
JIA
Enzymatic Methods, Galactose
1
Product Code
JIB
U.V. Method, Galactose
1
Product Code
JIC
Colorimetric Method, Galactose
1
Product Code
JID
Photometric Method, Ammonia
1
Product Code
JIE
Method, Ion-Exchange, Ammonia
1
Product Code
JIF
Enzymatic Method, Ammonia
1
Product Code
JIG
Electrode, Ion-Specific Method, Ammonia
1
Product Code
JIJ
Wet Ash Method, Protein-Bound Iodine
1
Product Code
JIK
Dry Ash Method, Protein-Bound Iodine
1
Product Code
JIL
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
2
Product Code
JIM
Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative)
2
Product Code
JIN
Nitroprusside, Ketones (Urinary, Non-Quant.)
1
Product Code
JIQ
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
1
Product Code
JIR
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
1
Product Code
JIS
Calibrator, Primary
2
Product Code
JIT
Calibrator, Secondary
2
Product Code
JIW
Calibrator, Surrogate
2
Product Code
JIX
Calibrator, Multi-Analyte Mixture
2
Product Code
JIY
Photometric Method, Iron (Non-Heme)
1
Product Code
JIZ
Atomic Absorption, Iron (Non-Heme)
1
Product Code
JJA
Radio-Labeled Iron Method, Iron (Non-Heme)
1
Product Code
JJB
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
1
Product Code
JJR
Electrolyte Controls (Assayed And Unassayed)
1
Product Code
JJS
Controls For Blood-Gases, (Assayed And Unassayed)
1
Product Code
JJT
Enzyme Controls (Assayed And Unassayed)
1
Product Code
JJW
Urinalysis Controls (Assayed And Unassayed)
1
Product Code
JJX
Single (Specified) Analyte Controls (Assayed And Unassayed)
1
Product Code
JJY
Multi-Analyte Controls, All Kinds (Assayed)
1
Product Code
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
2
Product Code
JKB
Radioimmunoassay, Compound S (11-Deoxycortisol)
1
Product Code
JKC
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
1
Product Code
JKD
Radioimmunoassay, C-Peptides Of Proinsulin
1
Product Code
JKF
Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge
1
Product Code
JKG
L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase
1
Product Code
JKH
Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen
1
Product Code
JKJ
Fluorometric Measurement, Porphyrins
1
Product Code
JKL
Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry
1
Product Code
JKP
Chromium-51, Blood Volume
1
Product Code
JKR
Radioimmunoassay, Calcitonin
2
Product Code
JKW
N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin
1
Product Code
JKX
N-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin
1
Product Code
JKY
Oxalydihydrazide (Spectroscopic), Copper
1
Product Code
JKZ
Diethyldithiocarbamate (Colorimetric), Copper
1
Product Code
JLA
Conversion To Creatinine, Creatine
1
Product Code
JLB
Atp And Creatine Kinase (Enzymatic), Creatine
1
Product Code
JLC
Nitroprusside Reaction (Qualitative, Urine), Cystine
1
Product Code
JLD
Chromatographic, Cystine
1
Product Code
JLE
Radioimmunoassay, Desoxycorticosterone
1
Product Code
JLF
Radioimmunoassay, Etiocholanolone
1
Product Code
JLG
Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids
1
Product Code
JLH
Titrimetric, Fatty Acids
1
Product Code
JLI
Tetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid
1
Product Code
JLJ
Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate
2
Product Code
JLK
Sodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity
1
Product Code
JLL
Tubeless Analysis, Gastric Acidity
1
Product Code
JLN
Chromatographic, Glutathione
1
Product Code
JLO
Enzymatic (Glutathione Reductase), Glutathione
1
Product Code
JLP
Spectrophotometric Method, Pregnanediol
1
Product Code
JLQ
Spectrophotometric Method, Pregnanetriol
1
Product Code
JLR
Gas Chromatography, Pregnanetriol
1
Product Code
JLS
Radioimmunoassay, Progesterone
1
Product Code
JLT
Acid, Pyruvic, Enzymatic (U.V.)
1
Product Code
JLW
Radioimmunoassay, Thyroid-Stimulating Hormone
2
Product Code
JLX
Radioimmunoassay, 17-Hydroxyprogesterone
1
Product Code
JLY
Phosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid
1
Product Code
JLZ
Nadh, Phosphoglycerate Mutase, Atp (U.V.) 2,3-Diphosphoglyceric Acid
1
Product Code
JMA
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
1
Product Code
JMD
Radioimmunoassay, Total Estrogens, Nonpregnancy
1
Product Code
JME
Radioimmunoassay, Glucagon
1
Product Code
JMF
Radioimmunoassay, Human Placental Lactogen
2
Product Code
JMI
Chromatographic, Histidine
1
Product Code
JMJ
Microbiological, Histidine
1
Product Code
JMK
Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
1
Product Code
JMM
Column Chromatography & Color Development, Hydroxyproline
1
Product Code
JMN
Extraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline
1
Product Code
JMO
Ferrozine (Colorimetric) Iron Binding Capacity
1
Product Code
JMQ
M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)
1
Product Code
JMR
Immunochemical, Lysozyme (Muramidase)
1
Product Code
JMS
Acid, Oxalacetic And Nadh Oxidation (U.V.), Malic Dehydrogenase
1
Product Code
JMT
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
1
Product Code
JMW
2,4-Dinitrofluorobenzene (Spectroscopic), Nitrogen (Amino-Nitrogen)
1
Product Code
JMX
Ninhydrin, Nitrogen (Amino-Nitrogen)
1
Product Code
JMY
Citrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase
1
Product Code
JMZ
Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
1
Product Code
JNA
Vapor Pressure, Osmolality Of Serum & Urine
1
Product Code
JNB
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
2
Product Code
JNC
Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine
2
Product Code
JND
Nadp Reduction, 6-Phosphogluconate Dehydrogenase
1
Product Code
JNE
Glucose-6-Phosphate (Colorimetric), Phosphohexose Isomerase
1
Product Code
JNF
Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen
1
Product Code
JNG
Radioimmunoassay, Pregnenolone
1
Product Code
JNJ
Phosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase
1
Product Code
JNK
Beta-D-Fructose & Nadh Oxidation (U.V.), Sorbitol Dehydrogenase
1
Product Code
JNN
P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin
1
Product Code
JNO
N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
1
Product Code
JNP
Infrared Spectroscopy Measurement, Urinary Calculi (Stone)
1
Product Code
JNQ
Qualitative Chemical Reactions, Urinary Calculi (Stone)
1
Product Code
JNS
Stannous Chloride - Hydrazine, Phospholipids
1
Product Code
JNT
Chromatographic, Phospholipids
1
Product Code
JNX
Membrane Osmometry, Plasma Oncometry
1
Product Code
JNY
Glyceralde-3-Phosphate, Nadh (Enzymatic), Triose Phosphate Isomerase
1
Product Code
JNZ
Fluorometric, Uroporphyrin
1
Product Code
JOA
Acid, Trifluoroacetic, Vitamin A, Hexane Extraction
1
Product Code
JOB
Hexane Extraction, Fluorescence, Vitamin E
1
Product Code
JOC
Colorimetric, Xylose
1
Product Code
JPZ
Colorimetric Method, Gamma-Glutamyl Transpeptidase
1
Product Code
JQA
Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes
1
Product Code
JQB
Kinetic Method, Gamma-Glutamyl Transpeptidase
1
Product Code
JQD
Resin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity
1
Product Code
JQE
Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
1
Product Code
JQF
Bathophenanthroline, Iron Binding Capacity
1
Product Code
JQG
Radiometric, Fe59, Iron Binding Capacity
1
Product Code
JQH
Trinitrobenzene Sulfonate (Spectroscopic), Nitrogen (Amino-Nitrogen)
1
Product Code
JQI
Rotating Disc, Plasma Viscometry
1
Product Code
JQJ
Densitometeric, Protein Fractionation
1
Product Code
JQK
Immunodiffusion, Protein Fractionation
1
Product Code
JQL
Spectrophotometric, Uroporphyrin
1
Product Code
JQM
P-Bromoaniline, Xylose
1
Product Code
JQN
Colorimetric, Mucopolysaccharides
1
Product Code
KHM
Nephelometric, Amylase
2
Product Code
KHP
Acid, Lactic, Enzymatic Method
1
Product Code
KHQ
Radioassay, Triiodothyronine Uptake
2
Product Code
KHS
Enzymatic, Carbon-Dioxide
2
Product Code
KLI
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
2
Product Code
KLJ
Nad Reduction (U.V.), Phosphohexose Isomerase
1
Product Code
KMS
Phenolphthalein Colorimetry, Carbon-Dioxide
2
Product Code
KNK
Acid, Uric, Uricase (Colorimetric)
1
Product Code
KQN
Radioassay, Angiotensin Converting Enzyme
2
Product Code
KQP
Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
2
Product Code
KWW
Radioimmunoassay, Cholyglycine, Bile Acids
2
Product Code
KWX
Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids
2
Product Code
LBR
Ldl & Vldl Precipitation, Hdl
1
Product Code
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
1
Product Code
LBT
Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
1
Product Code
LCH
Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
1
Product Code
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
2
Product Code
LFP
Conductivity Rate, Urea Nitrogen
2
Product Code
LFQ
Acid, Uric, Acid Reduction Of Ferric Ion
1
Product Code
LFR
Glucose Dehydrogenase, Glucose
2
Product Code
LFS
Radioreceptor Assay, Human Chorionic Gonadotropin
2
Product Code
LIG
Radioassay, Intrinsic Factor Blocking Antibody
2
Product Code
LPS
Urinary Homocystine (Nonquantitative) Test System
2
Product Code
LPT
System, Test, Urinary Methylmalonic Acid
2
Product Code
LPW
System, Test, Oxalate
1
Product Code
MMI
Immunoassay Method, Troponin Subunit
2
Product Code
MPG
Urinary Carbohydrate Analysis Kit
1
Product Code
MQM
Bilirubin (Total And Unbound) In The Neonate Test System
1
Product Code
MRG
System, Test, Vitamin D
2
Product Code
MRR
System, Test, Low Density, Lipoprotein
1
Product Code
MRV
Drink, Glucose Tolerance
2
Product Code
MSJ
Apolipoproteins
1
Product Code
MSM
System, Test, Lipoprotein(A)
1
Product Code
MYT
Biosensor, Immunoassay, Cpk Or Isoenzymes
2
Product Code
MZU
System, Test, Sodium, Enzymatic Method
2
Product Code
MZV
Test, System, Potassium, Enzymatic Method
2
Product Code
NAK
System, Test, Biotinidase
2
Product Code
NAL
Test, Immunoassay, Biosensor, Hcg
2
Product Code
NAO
Test, Carbohydrate Deficient Transferrin
1
Product Code
NAQ
Lipoprotein, High Density, Hdl, Over The Counter
1
Product Code
NBC
Test, Natriuretic Peptide
2
Product Code
NBW
System, Test, Blood Glucose, Over The Counter
2
Product Code
NDR
Enzyme Immunoassay, Inhibin-A
1
Product Code
NDY
Test, Cystatin C
2
Product Code
NEO
System, Test, Osteocalcin
2
Product Code
NHG
Enzyme Immunoassay, Cortisol, Salivary
2
Product Code
NJV
Test, Albumin Cobalt Binding
2
Product Code
NQL
System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
2
Product Code
NQM
Immunoassay For Detection Of Amniotic Fluid Protein(S).
1
Product Code
NRH
System, Breath Measurement
1
Product Code
OAM
Immunoassay, Insulin-Like Growth Factor Binding Protein-1
1
Product Code
OHQ
Multi-Analyte Controls Unassayed
1
Product Code
OLD
Internal Polymerase Chain Reaction Control, Not Assay Specific
1
Product Code
OND
Osmolality Of Tears
1
Product Code
OSX
Galectin-3 In Vitro Diagnostic Assay
2
Product Code
OYG
St2 Assay
2
Product Code
OYJ
Dna Specimen Collection, Saliva
2
Product Code
PDJ
Hemoglobin A1c Test System
2
Product Code
PDS
Amniotic Fluid Protein Immunoassay
1
Product Code
PFQ
Mmp-9 Test System
1
Product Code
PIG
Acute Kidney Injury Test System
2
Product Code
PJC
Newborn Screening Specimen Collection Paper
2
Product Code
PJD
Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
2
Product Code
PJE
Blood/Plasma Collection Device For Dna Testing
2
Product Code
PJT
Continuous Glucose Monitor Secondary Display
2
Product Code
PKU
Insulin Pump Secondary Display
2
Product Code
PQD
Blood Specimen Collection Convenience Kit (Excludes Hiv)
2
Product Code
PRJ
Capillary Blood Collection Device For Alternative Site Collection
2
Product Code
PSL
25-Oh-Vitamin D Mass Spectrometry Test System
2
Product Code
PTC
Uric Acid Test System For At Home Prescription Use
1
Product Code
PYP
Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test
1
Product Code
PYV
Hospital Continuous Glucose Monitoring System
2
Product Code
PZI
Prescription Use Blood Glucose Meter For Near-Patient Testing
2
Product Code
QBJ
Integrated Continuous Glucose Monitoring System, Factory Calibrated
2
Product Code
QCC
Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
2
Product Code
QDK
Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management
2
Product Code
QDL
Integrated Continuous Glucose Monitoring System For Professional Retrospective Use
2
Product Code
QII
Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use
2
Product Code
QJI
Interoperable Automated Glycemic Controller
2
Product Code
QJS
Interoperable Automated Glycemic Controller, Insulin Suspend
2
Product Code
QLG
Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
2
Product Code
QMA
Blood Collection Device For Cell-Free Nucleic Acid
2
Product Code
QQB
Prognostic Test For Assessment Of Liver Related Disease Progression
2
Product Code
OJQ
Cardiac Allograft Gene Expression Profiling Test System
2
Product Code
QRX
Continuous Glucose Monitor Informed Insulin Dose Calculator
2
Product Code
QZG
Menstrual Blood Collection Device
2
Product Code
SAF
Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
2
Product Code
SBH
Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
2
Product Code
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
Subpart C—Microbiology Devices
CFR Sub-Part
Subpart D—Clinical Toxicology Test Systems
CFR Sub-Part
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
Subpart D—Serological Reagents
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 2 May 2025 at 11:05 pm
CH
/
subpart-b—clinical-chemistry-test-systems
/
CEP
/
K853837
View Source
LH/FSH RADIOIMMUNOASSAY KIT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K853837
510(k) Type
Traditional
Applicant
BIOCLINICAL GROUP
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/16/1985
Days to Decision
30 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Miscellaneous
Subpart B—Biological Stains
Subpart B—Clinical Chemistry Test Systems
CDN
Urease, Photometric, Urea Nitrogen
CDO
Acid, Uric, Uricase (U.V.)
CDP
Radioimmunoassay, Total Triiodothyronine
CDE
Chromatographic Separation/Zimmerman, 17-Ketosteroids
CHA
Radioimmunoassay, Corticosterone
CDF
Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
CDG
Chromatography Separation/Zimmerman 17-Ketogenic Steroids
CDH
Acid, Uric, Phosphotungstate Reduction
CDK
Acid, Vanilmandelic, Electrophoretic Separation
CDL
Berthelot Indophenol, Urea Nitrogen
CDM
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
CCY
Zimmerman (Spectrophotometric), 17-Ketosteroids
CCZ
Zimmerman/Norymberski, 17-Ketogenic Steroids
CDA
Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
CDB
Porter Silber Hydrazone, 17-Hydroxycorticosteroids
CDC
L-Leucyl B-Naphthylamide, Leucine Aminopeptidase
CDD
Radioassay, Vitamin B12
CDQ
Urease And Glutamic Dehydrogenase, Urea Nitrogen
CDR
1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine
CDS
Electrode, Ion Specific, Urea Nitrogen
CDT
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
CDW
Diacetyl-Monoxime, Urea Nitrogen
CDX
Radioimmunoassay, Total Thyroxine
CDZ
Radioimmunoassay, Testosterones And Dihydrotestosterone
CEA
Tlc Chromatographic Separation Triglycerides
CEC
Radioimmunoassay, Free Thyroxine
CED
5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
CEE
Radioimmunoassay, Thyroxine-Binding Globulin
CEF
Electrophoretic, Protein Fractionation
CEI
Uranyl Acetate/Zinc Acetate, Sodium
CEJ
Tetraphenyl Borate, Colorimetry, Potassium
CEK
Biuret (Colorimetric), Total Protein
CEL
Ammonium Molybdate And Ammonium Vanadate, Phospholipids
CEM
Electrode, Ion Specific, Potassium
CEN
Dye-Indicator, Ph (Urinary, Non-Quantitative)
CEO
Phosphomolybdate (Colorimetric), Inorganic Phosphorus
CEP
Radioimmunoassay, Luteinizing Hormone
K
01
3582
MAYBE?MOM MINI OVULATION MICROSCOPE
K
02
2829
INSTANT-VIEW LH OVULATION PREDICTING TEST
K
02
1409
AT HOME OVULATION TEST, MODEL 9032
K
01
3874
CLEARPLANE EASY OVULATION TEST
K
01
3323
TCI-31 LIFELONG OVULATION TESTER
K
01
2252
QUIK-CHECK OVULATION PREDICTOR
K
01
0244
SURE CHECK OVULATION PREDICTOR
K
00
2867
INVERNESS MEDICAL OVULATION PREDICTOR TEST
K
99
1466
EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)
K
99
1386
EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)
K
99
0249
OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031
K
98
3113
BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT
K
98
1271
CLEARPLAN EASY OVULATION TEST
K
97
4508
DBEST ONE-STEP OVULATION TEST
K
97
3310
TBD* ONE-STEP OVULATION PREDICTOR TEST
K
97
0467
EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT
K
96
4982
VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)
K
96
4694
ELECSYS LH ASSAY
K
96
4925
SEALITE SCIENCES, INC. AQUALITE LH
K
96
3693
OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST
K
96
2866
OPUS HLH
K
96
2041
ACS LH2 IMMUNOASSAY
K
96
0233
MINICLINIC OVULATION PREDICTOR
K
96
1109
ACTIVE LH IRMA
K
95
3581
FIRST RESPONSE OVULATION PREDICTOR TEST
K
95
3063
CONCEIVE OVULATION PREDICTOR
K
95
1538
BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT
K
95
1748
COAT-A-COUNT LH IRMA
K
93
5319
CHEMILUMINESCENCE LH
K
94
3252
PRO-STEP LH OVULATION PREDICTION TEST
K
94
3996
DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD
K
94
3188
SEALITE SCIENCE, INC. AQUALITE(R) LH
K
94
2638
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
K
94
0549
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
K
93
5134
ONE STEP LH TEST
K
93
0306
COBAS CORE LH EIA
K
92
6394
VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
K
93
0185
OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP
K
92
2944
IMMUCHEM LH-MW ELISA
K
92
1176
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K
92
0920
ELISA TUBE LH TEST KIT
K
92
0411
IMMULITE HLH
K
92
0160
LH GEN III SELF-TEST/CONCEIVE
K
92
0504
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
K
91
3938
OPUS(R) LH TEST SYSTEM
K
91
1050
LH IRMA IMMUNOMAG
K
91
0351
MINICLINIC OVULATION PREDICTION TEST
K
91
0717
PANTEX IRMA LH 1251 KIT
K
91
0198
CIBA CORNING ACS LH IMMUNOASSAY
K
90
4387
BIOCLONES ELEGANCE LH ELISA KIT
K
90
2786
MILENIA (TM) LH
K
90
3052
IMMUNOCORP LH IRMA COATED TUBE
K
90
2443
LUMATAG(TM) LH DIAGNOSTIC KIT
K
90
2208
MODIFIED OVUGEN
K
90
2398
CIBA CORNING MAGIC LITE LH IMMUNOASSAY
K
90
0779
ENZYMUN TEST(R) LH
K
90
0621
FIAGEN(TM) HLH.S
K
89
6866
LUTEINIZING HORMONE-EIA-XT
K
89
6642
MODIFIED LH ENZYME IMMUNOASSAY TEST KIT
K
89
5094
TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT
K
89
4579
CLEARPLAN EASY
K
89
4279
LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST
K
89
1762
MINICLINIC OVULATION PREDICTION TEST
K
89
3605
SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY
K
89
0510
ABBOTT OVULATION PREDICTOR TEST
K
88
3814
DELFIA HLH SPEC KIT
K
88
4498
COTUBE LH IRMA ASSAY
K
88
3530
FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST
K
88
4138
ABBOTT IMX LH
K
88
2340
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA
K
88
2252
PHASE II LH KIT
K
88
0933
AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST
K
88
1124
ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY
K
88
0758
SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY
K
87
4624
FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301
K
87
4032
IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5
K
87
0584
O.P.T.(TM) OVULATION PREDICTION TEST
K
87
3534
OVUGEN SURETEST
K
87
3668
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
K
87
1241
ANSWER OVULATION TEST KIT
K
87
3186
LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA
K
87
3052
STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY
K
87
2131
TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY
K
87
2727
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE
K
87
1332
CLEARPLAN
K
87
1726
OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)
K
87
1602
MICROCHECK LH OVULATION TEST
K
86
3934
DPC COAT-A-COUNT IRMA LH KIT
K
86
3442
UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE
K
86
2055
CANWEST OVU-BLUE
K
86
4144
LUTEINIZING HORMONE (LH-IRMA) RIA KIT
K
86
3929
TERUMO SENSIBEAD(TM) EIA HLH KIT
K
86
3679
ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM
K
86
1354
RIGHT-DAY OVULATION HOME TEST
K
86
0828
FORETEL, COLOR OVULATION TEST
K
86
0538
RIGHT-DAY URINARY LH (EIA)
K
86
2180
MODIFIED COTROPIN RADIOIMMUNOASSAY KIT
K
86
0984
TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT
K
86
0334
VISI-CHECK HLH TEST MONOCLONAL
K
86
0333
MICRO-ELISA HLH TEST KIT MONOCLONAL
K
86
0308
SUCROSEP LUTEINIZING HORMONE (LH) IRMA
K
85
5173
DELFIA TM HLH KIT
K
85
4838
LEE-BEAD BETA LH (EIA)
K
85
3142
OVUTIME OVULATION PREDICTOR TEST
K
85
3837
LH/FSH RADIOIMMUNOASSAY KIT
K
85
2146
QUIDEL QUEST OVULATION TEST
K
85
1445
COLOR OVULATION TEST
K
85
2376
SIMULTANEOUS LH/FSH SYSTEM BY RIA
K
85
1332
BLHI LUTEINIZING HORMONE
K
85
1104
AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT
K
85
0480
OVU STICK SELF-TEST -MODIFICATION
K
84
3284
OVUSTICK SELF-TEST
K
84
1545
ENZYME IMMUNOASSAY FOR DETECTION HORM
K
84
2445
LH RIA
K
84
0412
OVU STICK URINE HLH KIT
K
84
0188
MICROMEDIC LH & FSH RIA KIT
K
84
0174
LH QUIK RIA KIT
K
83
3854
LH RIA
K
83
3376
RIANEN LUTEINIZING HORMONE RIA KIT
K
82
3476
GAMMADAB LH RADIO-KIT #CA-1508
K
82
3380
125-I LH RADIOIMMUNOASSAY KIT
K
82
2288
LH (125I) RADIOIMMUNOASSAY
K
82
1346
QUANTIMUNE HLH RIA
K
82
0760
LH RADIOIMMUNOASSAY TEST SYSTEM
K
82
0741
MR1 LUTROPIN RIA KIT
K
82
0753
AMERLEX LH RIA KIT (CODE IM2081)
K
82
0357
LUTEINIZING HORMONE KIT
K
81
3213
SHARIA-LH RIA KIT FOR QUANTITATION HORMO
K
81
1994
RADIOIMMUNOASSAY LUTEINIZING HORMONE
K
81
1024
LUTEINIZING HORMONE DIRECT RIA KIT 125/I
K
81
0754
LUTENIZING HORMONES
K
81
0741
LUTEINIZING HORMONE
K
81
0662
LEECO LH-QUANT DIAGNOSTIC KIT
K
81
0302
QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM
K
80
3278
LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT
K
80
0106
LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS
K
79
2350
CENTRIA LH RIA
K
79
2000
LUTEINIZING HORMONE (LH) RIA
K
79
1405
125I LEUTINIZING HORMONE RIA KIT
K
78
1685
RIA KIT, LH
K
78
0576
125-I LABELED HUMAN LUTEINIZING HORMONE
K
78
0367
RIA SYS. FOR HUMAN LUTEINIZING HORMONE
K
77
0854
LUTEINIZING HORMONE RIA REAGENT, LH-RIA
CEQ
Molybdenum Blue Method, Phospholipids
CER
2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase
CES
Chromogenesis, Phenylketones (Urinary, Non-Quant.)
CET
Olive Oil Emulsion (Turbidimetric), Lipase
CEW
Radioimmunoassay, Parathyroid Hormone
CEX
Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
CFA
Electrode, Ion Specific, Magnesium
CFB
Chromatographic Derivative, Total Lipids
CFD
Sulfophosphovanillin, Colorimetry, Total Lipids
CFE
Electrophoretic, Lactate Dehydrogenase Isoenzymes
CFG
Oil Emulsion/Thymolphthalein (Titrimetric), Lipase
CFH
Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
CFJ
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
CFL
Radioimmunoassay, Human Growth Hormone
CFM
Bathophenanthroline, Colorimetry, Iron (Non-Heme)
CFO
Titrimetric, Magnesium
CFP
Radioimmunoassay, Immunoreactive Insulin
CFR
Hexokinase, Glucose
CFT
Radioimmunoassay, Prolactin (Lactogen)
CFW
Copper Reduction, Glucose
CGA
Glucose Oxidase, Glucose
CGC
Radioimmunoassay, Gastrin
CGD
Ferricyanide, Glucose
CGE
Orthotoluidine, Glucose
CGF
Radioimmunoassay, Estrone
CGH
Electrophoretic, Globulin
CGI
Radioimmunoassay, Estriol
CGJ
Radioimmunoassay, Follicle-Stimulating Hormone
CGL
Electrode, Ion Based, Enzymatic, Creatinine
CGN
Acid, Folic, Radioimmunoassay
CGO
Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
CGR
Radioimmunoassay, Cortisol
CGS
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
CGT
Radioimmunoassay, Cyclic Gmp
CGX
Alkaline Picrate, Colorimetry, Creatinine
CGZ
Electrode, Ion-Specific, Chloride
CHC
Titrimetric Permanganate And Bromophenol Blue, Calcium
CHD
Acid, Ferric Ion-Sulfuric, Cholesterol
CHE
Radioimmunoassay, Corticoids
CHG
Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride
CHH
Enzymatic Esterase--Oxidase, Cholesterol
CHI
Lipase-Esterase, Enzymatic, Photometric, Lipase
CHJ
Mercuric Thiocyanate, Colorimetry, Chloride
CHK
Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride
CHL
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
CHM
Radioimmunoassay, Total Estrogens In Pregnancy
CHO
Radioimmunoassay, Cyclic Amp
CHP
Radioimmunoassay, Estradiol
CHQ
Chromatographic/Fluorometric Method, Catecholamines
CHR
Titrimetric Phenol Red, Carbon-Dioxide
CHS
Coulometric Method, Carbon-Dioxide
CHT
Electrophoretic Method, Catecholamines
CHW
Titrimetric With Edta And Indicator, Calcium
CHZ
Di (O-Hydroxyphenylimine) Ethane, Calcium
CIA
Methylthymol Blue, Calcium
CIB
Radioimmunoassay, Angiotensin I And Renin
CIC
Cresolphthalein Complexone, Calcium
CID
Alizarin Sulfonate, Calcium
CIE
Volumetric/Manometric, Carbon-Dioxide
CIF
Vanillin Pyruvate, Ast/Sgot
CIG
Diazo Colorimetry, Bilirubin
CIJ
Saccharogenic, Amylase
CIK
Radial Diffusion, Amylase
CIL
Cresol Red Colorimetry, Carbon-Dioxide
CIN
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
CIO
Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
CIQ
Diazo, Ast/Sgot
CIS
Hydrazone Colorimetry, Ast/Sgot
CIT
Nadh Oxidation/Nad Reduction, Ast/Sgot
CIW
Starch-Dye Bound Polymer, Amylase
CIX
Bromcresol Green Dye-Binding, Albumin
CIY
Radioimmunoassay, Androsterone
CIZ
Radioimmunoassay, Androstenedione
CJA
Amyloclastic, Amylase
CJB
Chromatographic Separation/Radioimmunoassay, Aldosterone
CJC
Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase
CJD
Nitrosalicylate Reduction, Amylase
CJE
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
CJF
Tetrabromophenolphthalein, Albumin
CJG
Tetrabromo-M-Cresolsulfonphthalein, Albumin
CJH
Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes
CJI
Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
CJJ
Diazo, Alt/Sgpt
CJK
Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes
CJL
Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes
CJM
Radioimmunoassay, Aldosterone
CJN
Acid Phosphatase, Nitrophenylphosphate
CJO
Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
CJQ
Radial Immunodiffusion, Albumin
CJR
Acid Phosphatase, Thymol Blue Monophosphate
CJT
Hydrazone Colorimetry, Aldolase
CJW
Bromcresol Purple Dye-Binding, Albumin
CJX
Acid Phosphatase, Disodium Phenylphosphate
CJY
Azo Dye, Calcium
CJZ
Acid, Hydroxyazobenzene-Benzoic, Albumin
CKA
Nadh Oxidation/Nad Reduction, Alt/Sgpt
CKB
Acid Phosphatase, Naphthyl Phosphate
CKC
Vanillin Pyruvate, Alt/Sgpt
CKD
Hydrazone Colorimetry, Alt/Sgpt
CKE
Acid Phosphatase, Thymolphthale Inmonophosphate
CKF
Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
CKG
Radioimmunoassay, Acth
CKH
Acid Phosphatase, Beta Glycerophosphate
DHA
System, Test, Human Chorionic Gonadotropin
GIM
Tubes, Vacuum Sample, With Anticoagulant
GJE
Tray, Blood Collection
JFH
Acid Phosphatase (Prostatic), Tartrate Inhibited
JFJ
Catalytic Methods, Amylase
JFL
Ph Rate Measurement, Carbon-Dioxide
JFM
Enzymatic Method, Bilirubin
JFN
Atomic Absorption, Calcium
JFO
Fluorometric, Calcium
JFP
Electrode, Ion Specific, Calcium
JFS
Coulometric, Chloride
JFT
Fluorometric, Cortisol
JFY
Enzymatic Method, Creatinine
JGC
Tryptophan Measurement (Colorimetric), Globulin
JGD
Nephelometric Method, Globulin
JGE
Turbidimetric Method, Globulin
JGF
Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
JGG
L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase
JGI
Atomic Absorption, Magnesium
JGJ
Photometric Method, Magnesium
JGK
Ferric Chloride, Phenylketones (Urinary, Non-Quant.)
JGM
Flame Photometry, Potassium
JGP
Lowry (Colorimetric), Total Protein
JGQ
Turbidimetric, Total Protein
JGR
Refractometric, Total Protein
JGS
Electrode, Ion Specific, Sodium
JGT
Flame Photometry, Sodium
JGW
Fluorometric Method, Triglycerides
JGX
Turbidimetric Method, Triglycerides
JGY
Colorimetric Method, Triglycerides
JGZ
O-Phthalaldehyde, Urea Nitrogen
JHA
Acid, Uric, Uricase (Gasometric)
JHC
Acid, Uric, Uricase (Oxygen Rate)
JHD
Fluorometric Method, 17-Hydroxycorticosteroids
JHE
Radioassay, 17-Hydroxycorticosteroids
JHF
Colorimetric Method, Lecithin/Sphingomyelin Ratio
JHG
Chromatographic Separation, Lecithin/Sphingomyelin Ratio
JHH
Electrophoretic Method, Lecithin/Sphingomyelin Ratio
JHI
Visual, Pregnancy Hcg, Prescription Use
JHJ
Agglutination Method, Human Chorionic Gonadotropin
JHL
Microdensitometry Method, Lipoproteins
JHM
Colorimetric Method, Lipoproteins
JHN
Turbidimetric Method, Lipoproteins
JHO
Electrophoretic Separation, Lipoproteins
JHP
Radial Immunodiffusion, Lipoproteins
JHQ
Nephelometric Method, Lipoproteins
JHS
Differential Rate Kinetic Method, Cpk Or Isoenzymes
JHT
Chromatographic Separation, Cpk Isoenzymes
JHW
U.V. Method, Cpk Isoenzymes
JHX
Fluorometric Method, Cpk Or Isoenzymes
JHY
Colorimetric Method, Cpk Or Isoenzymes
JIA
Enzymatic Methods, Galactose
JIB
U.V. Method, Galactose
JIC
Colorimetric Method, Galactose
JID
Photometric Method, Ammonia
JIE
Method, Ion-Exchange, Ammonia
JIF
Enzymatic Method, Ammonia
JIG
Electrode, Ion-Specific Method, Ammonia
JIJ
Wet Ash Method, Protein-Bound Iodine
JIK
Dry Ash Method, Protein-Bound Iodine
JIL
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
JIM
Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative)
JIN
Nitroprusside, Ketones (Urinary, Non-Quant.)
JIQ
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
JIR
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
JIS
Calibrator, Primary
JIT
Calibrator, Secondary
JIW
Calibrator, Surrogate
JIX
Calibrator, Multi-Analyte Mixture
JIY
Photometric Method, Iron (Non-Heme)
JIZ
Atomic Absorption, Iron (Non-Heme)
JJA
Radio-Labeled Iron Method, Iron (Non-Heme)
JJB
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
JJR
Electrolyte Controls (Assayed And Unassayed)
JJS
Controls For Blood-Gases, (Assayed And Unassayed)
JJT
Enzyme Controls (Assayed And Unassayed)
JJW
Urinalysis Controls (Assayed And Unassayed)
JJX
Single (Specified) Analyte Controls (Assayed And Unassayed)
JJY
Multi-Analyte Controls, All Kinds (Assayed)
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
JKB
Radioimmunoassay, Compound S (11-Deoxycortisol)
JKC
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
JKD
Radioimmunoassay, C-Peptides Of Proinsulin
JKF
Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge
JKG
L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase
JKH
Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen
JKJ
Fluorometric Measurement, Porphyrins
JKL
Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry
JKP
Chromium-51, Blood Volume
JKR
Radioimmunoassay, Calcitonin
JKW
N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin
JKX
N-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin
JKY
Oxalydihydrazide (Spectroscopic), Copper
JKZ
Diethyldithiocarbamate (Colorimetric), Copper
JLA
Conversion To Creatinine, Creatine
JLB
Atp And Creatine Kinase (Enzymatic), Creatine
JLC
Nitroprusside Reaction (Qualitative, Urine), Cystine
JLD
Chromatographic, Cystine
JLE
Radioimmunoassay, Desoxycorticosterone
JLF
Radioimmunoassay, Etiocholanolone
JLG
Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids
JLH
Titrimetric, Fatty Acids
JLI
Tetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid
JLJ
Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate
JLK
Sodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity
JLL
Tubeless Analysis, Gastric Acidity
JLN
Chromatographic, Glutathione
JLO
Enzymatic (Glutathione Reductase), Glutathione
JLP
Spectrophotometric Method, Pregnanediol
JLQ
Spectrophotometric Method, Pregnanetriol
JLR
Gas Chromatography, Pregnanetriol
JLS
Radioimmunoassay, Progesterone
JLT
Acid, Pyruvic, Enzymatic (U.V.)
JLW
Radioimmunoassay, Thyroid-Stimulating Hormone
JLX
Radioimmunoassay, 17-Hydroxyprogesterone
JLY
Phosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid
JLZ
Nadh, Phosphoglycerate Mutase, Atp (U.V.) 2,3-Diphosphoglyceric Acid
JMA
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
JMD
Radioimmunoassay, Total Estrogens, Nonpregnancy
JME
Radioimmunoassay, Glucagon
JMF
Radioimmunoassay, Human Placental Lactogen
JMI
Chromatographic, Histidine
JMJ
Microbiological, Histidine
JMK
Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
JMM
Column Chromatography & Color Development, Hydroxyproline
JMN
Extraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline
JMO
Ferrozine (Colorimetric) Iron Binding Capacity
JMQ
M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)
JMR
Immunochemical, Lysozyme (Muramidase)
JMS
Acid, Oxalacetic And Nadh Oxidation (U.V.), Malic Dehydrogenase
JMT
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
JMW
2,4-Dinitrofluorobenzene (Spectroscopic), Nitrogen (Amino-Nitrogen)
JMX
Ninhydrin, Nitrogen (Amino-Nitrogen)
JMY
Citrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase
JMZ
Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
JNA
Vapor Pressure, Osmolality Of Serum & Urine
JNB
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
JNC
Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine
JND
Nadp Reduction, 6-Phosphogluconate Dehydrogenase
JNE
Glucose-6-Phosphate (Colorimetric), Phosphohexose Isomerase
JNF
Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen
JNG
Radioimmunoassay, Pregnenolone
JNJ
Phosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase
JNK
Beta-D-Fructose & Nadh Oxidation (U.V.), Sorbitol Dehydrogenase
JNN
P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin
JNO
N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
JNP
Infrared Spectroscopy Measurement, Urinary Calculi (Stone)
JNQ
Qualitative Chemical Reactions, Urinary Calculi (Stone)
JNS
Stannous Chloride - Hydrazine, Phospholipids
JNT
Chromatographic, Phospholipids
JNX
Membrane Osmometry, Plasma Oncometry
JNY
Glyceralde-3-Phosphate, Nadh (Enzymatic), Triose Phosphate Isomerase
JNZ
Fluorometric, Uroporphyrin
JOA
Acid, Trifluoroacetic, Vitamin A, Hexane Extraction
JOB
Hexane Extraction, Fluorescence, Vitamin E
JOC
Colorimetric, Xylose
JPZ
Colorimetric Method, Gamma-Glutamyl Transpeptidase
JQA
Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes
JQB
Kinetic Method, Gamma-Glutamyl Transpeptidase
JQD
Resin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity
JQE
Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
JQF
Bathophenanthroline, Iron Binding Capacity
JQG
Radiometric, Fe59, Iron Binding Capacity
JQH
Trinitrobenzene Sulfonate (Spectroscopic), Nitrogen (Amino-Nitrogen)
JQI
Rotating Disc, Plasma Viscometry
JQJ
Densitometeric, Protein Fractionation
JQK
Immunodiffusion, Protein Fractionation
JQL
Spectrophotometric, Uroporphyrin
JQM
P-Bromoaniline, Xylose
JQN
Colorimetric, Mucopolysaccharides
KHM
Nephelometric, Amylase
KHP
Acid, Lactic, Enzymatic Method
KHQ
Radioassay, Triiodothyronine Uptake
KHS
Enzymatic, Carbon-Dioxide
KLI
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
KLJ
Nad Reduction (U.V.), Phosphohexose Isomerase
KMS
Phenolphthalein Colorimetry, Carbon-Dioxide
KNK
Acid, Uric, Uricase (Colorimetric)
KQN
Radioassay, Angiotensin Converting Enzyme
KQP
Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
KWW
Radioimmunoassay, Cholyglycine, Bile Acids
KWX
Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids
LBR
Ldl & Vldl Precipitation, Hdl
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
LBT
Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
LCH
Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
LFP
Conductivity Rate, Urea Nitrogen
LFQ
Acid, Uric, Acid Reduction Of Ferric Ion
LFR
Glucose Dehydrogenase, Glucose
LFS
Radioreceptor Assay, Human Chorionic Gonadotropin
LIG
Radioassay, Intrinsic Factor Blocking Antibody
LPS
Urinary Homocystine (Nonquantitative) Test System
LPT
System, Test, Urinary Methylmalonic Acid
LPW
System, Test, Oxalate
MMI
Immunoassay Method, Troponin Subunit
MPG
Urinary Carbohydrate Analysis Kit
MQM
Bilirubin (Total And Unbound) In The Neonate Test System
MRG
System, Test, Vitamin D
MRR
System, Test, Low Density, Lipoprotein
MRV
Drink, Glucose Tolerance
MSJ
Apolipoproteins
MSM
System, Test, Lipoprotein(A)
MYT
Biosensor, Immunoassay, Cpk Or Isoenzymes
MZU
System, Test, Sodium, Enzymatic Method
MZV
Test, System, Potassium, Enzymatic Method
NAK
System, Test, Biotinidase
NAL
Test, Immunoassay, Biosensor, Hcg
NAO
Test, Carbohydrate Deficient Transferrin
NAQ
Lipoprotein, High Density, Hdl, Over The Counter
NBC
Test, Natriuretic Peptide
NBW
System, Test, Blood Glucose, Over The Counter
NDR
Enzyme Immunoassay, Inhibin-A
NDY
Test, Cystatin C
NEO
System, Test, Osteocalcin
NHG
Enzyme Immunoassay, Cortisol, Salivary
NJV
Test, Albumin Cobalt Binding
NQL
System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
NQM
Immunoassay For Detection Of Amniotic Fluid Protein(S).
NRH
System, Breath Measurement
OAM
Immunoassay, Insulin-Like Growth Factor Binding Protein-1
OHQ
Multi-Analyte Controls Unassayed
OLD
Internal Polymerase Chain Reaction Control, Not Assay Specific
OND
Osmolality Of Tears
OSX
Galectin-3 In Vitro Diagnostic Assay
OYG
St2 Assay
OYJ
Dna Specimen Collection, Saliva
PDJ
Hemoglobin A1c Test System
PDS
Amniotic Fluid Protein Immunoassay
PFQ
Mmp-9 Test System
PIG
Acute Kidney Injury Test System
PJC
Newborn Screening Specimen Collection Paper
PJD
Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
PJE
Blood/Plasma Collection Device For Dna Testing
PJT
Continuous Glucose Monitor Secondary Display
PKU
Insulin Pump Secondary Display
PQD
Blood Specimen Collection Convenience Kit (Excludes Hiv)
PRJ
Capillary Blood Collection Device For Alternative Site Collection
PSL
25-Oh-Vitamin D Mass Spectrometry Test System
PTC
Uric Acid Test System For At Home Prescription Use
PYP
Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test
PYV
Hospital Continuous Glucose Monitoring System
PZI
Prescription Use Blood Glucose Meter For Near-Patient Testing
QBJ
Integrated Continuous Glucose Monitoring System, Factory Calibrated
QCC
Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
QDK
Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management
QDL
Integrated Continuous Glucose Monitoring System For Professional Retrospective Use
QII
Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use
QJI
Interoperable Automated Glycemic Controller
QJS
Interoperable Automated Glycemic Controller, Insulin Suspend
QLG
Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
QMA
Blood Collection Device For Cell-Free Nucleic Acid
QQB
Prognostic Test For Assessment Of Liver Related Disease Progression
OJQ
Cardiac Allograft Gene Expression Profiling Test System
QRX
Continuous Glucose Monitor Informed Insulin Dose Calculator
QZG
Menstrual Blood Collection Device
SAF
Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
SBH
Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
Subpart B—Diagnostic Devices
Subpart C—Clinical Laboratory Instruments
Subpart C—Microbiology Devices
Subpart D—Clinical Toxicology Test Systems
Subpart D—Pathology Instrumentation and Accessories
Subpart D—Serological Reagents
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Immunological Test Systems
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
CH
/
subpart-b—clinical-chemistry-test-systems
/
CEP
/
K853837
View Source
LH/FSH RADIOIMMUNOASSAY KIT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K853837
510(k) Type
Traditional
Applicant
BIOCLINICAL GROUP
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/16/1985
Days to Decision
30 days