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Review Panel
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Review Panel
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Miscellaneous
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—Serological Reagents
CFR Sub-Part
Subpart E—Immunology Laboratory Equipment and Reagents
CFR Sub-Part
Subpart E—Specimen Preparation Reagents
CFR Sub-Part
Subpart F—Automated and Semi-Automated Hematology Devices
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
CZQ
Bence-Jones Protein, Antigen, Antiserum, Control
2
Product Code
CZR
Hemopexin, Rhodamine, Antigen, Antiserum, Control
2
Product Code
CZS
Retinol-Binding Protein, Antigen, Antiserum, Control
1
Product Code
CZT
Hemopexin, Fitc, Antigen, Antiserum, Control
2
Product Code
CZW
Complement C3, Antigen, Antiserum, Control
2
Product Code
CZX
Hemopexin, Antigen, Antiserum, Control
2
Product Code
CZY
Complement C1s, Antigen, Antiserum, Control
2
Product Code
CZZ
Haptoglobin, Rhodamine, Antigen, Antiserum, Control
2
Product Code
DAB
Haptoglobin, Fitc, Antigen, Antiserum, Control
2
Product Code
DAC
Complement C3b Activator, Antigen, Antiserum, Control
2
Product Code
DAD
Haptoglobin, Antigen, Antiserum, Control
2
Product Code
DAE
Complement C9, Antigen, Antiserum, Control
2
Product Code
DAF
Gamma Globulin, Fitc, Antigen, Antiserum, Control
2
Product Code
DAG
Complement C8, Antigen, Antiserum, Control
2
Product Code
DAH
Gamma Globulin, Antigen, Antiserum, Control
2
Product Code
DAI
Complement C1r, Antigen, Antiserum, Control
2
Product Code
DAJ
Free Secretory Component, Antigen, Antiserum, Control
2
Product Code
DAK
Complement C1q, Antigen, Antiserum, Control
2
Product Code
DAL
Fraction Iv-5, Antigen, Antiserum, Control
1
Product Code
DAM
Hemoglobin, Chain Specific, Antigen, Antiserum, Control
2
Product Code
DAN
Fibrinopeptide A, Antigen, Antiserum, Control
2
Product Code
DAO
Igm (Mu Chain Specific), Antigen, Antiserum, Control
2
Product Code
DAQ
Igg (Fd Fragment Specific), Antigen, Antiserum, Control
1
Product Code
DAS
Igg (Fc Fragment Specific), Antigen, Antiserum, Control
1
Product Code
CFF
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
2
Product Code
CFN
Method, Nephelometric, Immunoglobulins (G, A, M)
2
Product Code
CFQ
Radioimmunoassay, Immunoglobulins (G, A, M)
2
Product Code
CGM
Method, Immunodiffusion, Immunoglobulins (G, A, M)
2
Product Code
CHN
Immunochemical, Ceruloplasmin
2
Product Code
CZJ
Igd, Antigen, Antiserum, Control
2
Product Code
CZK
Iga, Rhodamine, Antigen, Antiserum, Control
2
Product Code
CZL
Iga, Peroxidase, Antigen, Antiserum, Control
2
Product Code
CZM
Iga, Ferritin, Antigen, Antiserum, Control
2
Product Code
CZN
Iga, Fitc, Antigen, Antiserum, Control
2
Product Code
CZO
Inter-Alpha Trypsin Inhibitor, Antigen, Antiserum, Control
1
Product Code
CZP
Iga, Antigen, Antiserum, Control
2
Product Code
DAW
Alpha-2-Ap-Glycoprotein, Antigen, Antiserum, Control
1
Product Code
DAY
Complement C5, Antigen, Antiserum, Control
2
Product Code
DBA
Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
2
Product Code
DBC
Alpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control
1
Product Code
DBE
Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
2
Product Code
DBF
Ferritin, Antigen, Antiserum, Control
2
Product Code
DBH
Fc, Rhodamine, Antigen, Antiserum, Control
1
Product Code
DBI
Complement C4, Antigen, Antiserum, Control
2
Product Code
DBJ
Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
2
Product Code
DBK
Fc, Fitc, Antigen, Antiserum, Control
1
Product Code
DBL
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
2
Product Code
DBM
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
2
Product Code
DBN
Fc, Antigen, Antiserum, Control
1
Product Code
DBY
Fab, Rhodamine, Antigen, Antiserum, Control
1
Product Code
DCB
Fab, Fitc, Antigen, Antiserum, Control
1
Product Code
DCE
Fab, Antigen, Antiserum, Control
1
Product Code
DCF
Albumin, Antigen, Antiserum, Control
2
Product Code
DCH
System, Test, C-Reactive Protein, Rhodamine
2
Product Code
DCJ
Beta-Globulin, Antigen, Antiserum, Control
1
Product Code
DCK
C-Reactive Protein, Antigen, Antiserum, And Control
2
Product Code
DCN
System, Test, C-Reactive Protein
2
Product Code
DCO
Alpha-Globulin, Antigen, Antiserum, Control
1
Product Code
DCT
Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control
2
Product Code
DCY
Ceruloplasmin, Fitc, Antigen, Antiserum, Control
2
Product Code
DDB
Ceruloplasmin, Antigen, Antiserum, Control
2
Product Code
DDC
Thyroglobulin, Antigen, Antiserum, Control
2
Product Code
DDD
Transferrin, Rhodamine, Antigen, Antiserum, Control
2
Product Code
DDG
Transferrin, Antigen, Antiserum, Control
2
Product Code
DDI
Transferrin, Fitc, Antigen, Antiserum, Control
2
Product Code
DDJ
Thyroglobulin, Fitc, Antigen, Antiserum, Control
2
Product Code
DDK
Beta-2-Glycoprotein Iii, Antigen, Antiserum, Control
1
Product Code
DDL
Thyroglobulin, Rhodamine, Antigen, Antiserum, Control
2
Product Code
DDN
Beta-2-Glycoprotein I, Antigen, Antiserum, Control
1
Product Code
DDO
Myoglobin, Rhodamine, Antigen, Antiserum, Control
2
Product Code
DDR
Myoglobin, Antigen, Antiserum, Control
2
Product Code
DDS
Prealbumin, Fitc, Antigen, Antiserum, Control
1
Product Code
DDT
Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control
2
Product Code
DDY
Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control
2
Product Code
DDZ
Albumin, Fitc, Antigen, Antiserum, Control
2
Product Code
DEA
Myoglobin, Fitc, Antigen, Antiserum, Control
2
Product Code
DEB
Alpha-2-Macroglobulin, Antigen, Antiserum, Control
2
Product Code
DEC
Inter-Alpha Trypsin Inhibitor, Fitc, Antigen, Antiserum, Control
1
Product Code
DEF
Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control
1
Product Code
DEG
Lactoferrin, Antigen, Antiserum, Control
1
Product Code
DEH
Lambda, Antigen, Antiserum, Control
2
Product Code
DEI
Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control
2
Product Code
DEJ
Alpha-2-Glycoproteins, Antigen, Antiserum, Control
1
Product Code
DEK
Kappa, Rhodamine, Antigen, Antiserum, Control
2
Product Code
DEL
Lipoprotein X, Antigen, Antiserum, Control
1
Product Code
DEM
Alpha-1-Antitrypsin, Antigen, Antiserum, Control
2
Product Code
DEN
Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control
1
Product Code
DEO
Kappa, Fitc, Antigen, Antiserum, Control
2
Product Code
DER
Alpha-1-Lipoprotein, Antigen, Antiserum, Control
2
Product Code
DES
Lambda, Fitc, Antigen, Antiserum, Control
2
Product Code
DET
Lactic Dehydrogenase, Antigen, Antiserum, Control
1
Product Code
DEW
Igg, Antigen, Antiserum, Control
2
Product Code
DEX
Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control
1
Product Code
DEZ
Igm, Rhodamine, Antigen, Antiserum, Control
2
Product Code
DFB
Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control
2
Product Code
DFC
Lipoprotein, Low-Density, Antigen, Antiserum, Control
2
Product Code
DFF
Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control
2
Product Code
DFG
Lambda, Rhodamine, Antigen, Antiserum, Control
2
Product Code
DFH
Kappa, Antigen, Antiserum, Control
2
Product Code
DFI
Total Spinal-Fluid, Antigen, Antiserum, Control
1
Product Code
DFJ
Albumin, Rhodamine, Antigen, Antiserum, Control
2
Product Code
DFK
Igg (Fab Fragment Specific), Antigen, Antiserum, Control
1
Product Code
DFL
Igm, Ferritin, Antigen, Antiserum, Control
2
Product Code
DFM
Ige, Ferritin, Antigen, Antiserum, Control
2
Product Code
DFO
Igg, Rhodamine, Antigen, Antiserum, Control
2
Product Code
DFQ
Sperm, Antigen, Antiserum, Control
1
Product Code
DFS
Igm, Fitc, Antigen, Antiserum, Control
2
Product Code
DFT
Igm, Antigen, Antiserum, Control
2
Product Code
DFX
Sperm, Fitc, Antigen, Antiserum, Control
1
Product Code
DFZ
Igg (Gamma Chain Specific), Antigen, Antiserum, Control
2
Product Code
DGA
Cohn Fraction Ii, Antigen, Antiserum, Control
1
Product Code
DGC
Ige, Antigen, Antiserum, Control
2
Product Code
DGD
Igg, Ferritin, Antigen, Antiserum, Control
2
Product Code
DGE
Igd, Rhodamine, Antigen, Antiserum, Control
2
Product Code
DGG
Igd, Fitc, Antigen, Antiserum, Control
2
Product Code
DGI
Breast Milk, Rhodamine, Antigen, Antiserum, Control
1
Product Code
DGJ
Colostrum, Antigen, Antiserum, Control
1
Product Code
DGK
Igg, Fitc, Antigen, Antiserum, Control
2
Product Code
DGL
Ige, Rhodamine, Antigen, Antiserum, Control
2
Product Code
DGM
Breast Milk, Antigen, Antiserum, Control
1
Product Code
DGN
Breast Milk, Fitc, Antigen, Antiserum, Control
1
Product Code
DGP
Ige, Fitc, Antigen, Antiserum, Control
2
Product Code
DGW
System, Test, Hypersensitivity Pneumonitis
2
Product Code
DGX
Ng1m(A), Antigen, Antiserum, Control
1
Product Code
DHB
System, Test, Radioallergosorbent (Rast) Immunological
2
Product Code
DHC
System, Test, Systemic Lupus Erythematosus
2
Product Code
DHI
Ng3m(Bo), Antigen, Antiserum, Control
1
Product Code
DHN
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
2
Product Code
DHQ
Ng3m(G), Antigen, Antiserum, Control
1
Product Code
DHR
System, Test, Rheumatoid Factor
2
Product Code
DHY
Ng4m(A), Antigen, Antiserum, Control
1
Product Code
JFQ
P-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin
2
Product Code
JFR
Indirect Copper Assay, Ceruloplasmin
2
Product Code
JHR
Radioimmunoassay, Immunoglobulins (D, E)
2
Product Code
JKM
Immunochemical, Bence-Jones Protein
2
Product Code
JNL
Immunochemical, Thyroglobulin Autoantibody
2
Product Code
JNM
Immunochemical, Transferrin
2
Product Code
JZG
System, Test, Beta-2-Microglobulin Immunological
2
Product Code
JZH
Factor B, Antigen, Antiserum, Control
2
Product Code
JZJ
Prealbumin, Antigen, Antiserum, Control
1
Product Code
JZO
System, Test, Thyroid Autoantibody
2
Product Code
K
24
0469
Access TPO Antibody
2
Cleared 510(K)
K
21
3517
Access Thyroglobulin Antibody II
2
Cleared 510(K)
K
22
2610
Elecsys Anti-Tg
2
Cleared 510(K)
K
19
3313
Elecsys Anti-TSHR
2
Cleared 510(K)
K
15
1799
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
2
Cleared 510(K)
K
15
2061
IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
2
Cleared 510(K)
K
09
2229
THYRETAIN TM TSI REPORTER BIOASSAY
2
Cleared 510(K)
K
09
0760
THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
2
Cleared 510(K)
K
08
3391
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
2
Cleared 510(K)
K
08
0092
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
2
Cleared 510(K)
K
08
0159
KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT
2
Cleared 510(K)
K
06
1794
FIDIS TM THYRO, MODEL MX002
2
Cleared 510(K)
K
05
2407
ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
2
Cleared 510(K)
K
06
1382
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
2
Cleared 510(K)
K
05
2308
ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
2
Cleared 510(K)
K
05
3426
ROCHE ELECSYS ANTI-TG
2
Cleared 510(K)
K
05
1890
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
2
Cleared 510(K)
K
03
3977
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
2
Cleared 510(K)
K
03
3454
BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN
2
Cleared 510(K)
K
03
2134
TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT
2
Cleared 510(K)
K
02
3593
SERAQUEST ANTI-THYROID PEROXIDASE (TPO)
2
Cleared 510(K)
K
02
0672
ELECSYS ANTI-TG TEST SYSTEM
2
Cleared 510(K)
K
02
0687
DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300
2
Cleared 510(K)
K
02
0349
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS
2
Cleared 510(K)
K
02
0348
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS
2
Cleared 510(K)
K
01
2777
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
2
Cleared 510(K)
K
01
1082
TPO IGG ANTIBODY EIA TEST
2
Cleared 510(K)
K
01
1415
ALPCO MILENIA ANTI-TG EIA
2
Cleared 510(K)
K
01
1201
ALPCO MILENIA ANTI-TPO ELISA
2
Cleared 510(K)
K
00
3291
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY
2
Cleared 510(K)
K
00
3414
VARELISA TG (THYROGLOBULIN) ANTIBODIES,
2
Cleared 510(K)
K
00
0155
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
2
Cleared 510(K)
K
00
0286
BRAHMS DIAGNOSTICA LUMITEST ANTI-TG
2
Cleared 510(K)
K
00
0287
BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO
2
Cleared 510(K)
K
00
0362
MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM
2
Cleared 510(K)
K
99
3585
VARELISA TPO ANTIBODIES, MODEL 12348/12396
2
Cleared 510(K)
K
99
2791
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO
2
Cleared 510(K)
K
99
2790
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG
2
Cleared 510(K)
K
99
1096
IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06
2
Cleared 510(K)
K
99
1094
IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6
2
Cleared 510(K)
K
98
4228
IS ANTI-TPO IGG ELISA TEST SYSTEM
2
Cleared 510(K)
K
98
4165
ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT
2
Cleared 510(K)
K
98
4163
ANTI-TPO EIA DIAGNOSTIC TEST KIT
2
Cleared 510(K)
K
98
3992
NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY
2
Cleared 510(K)
K
98
3553
ANTI-TG IGG ELISA TEST SYSTEM
2
Cleared 510(K)
K
98
2866
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521
2
Cleared 510(K)
K
98
1522
AIA-PACK TGAB ASSAY
2
Cleared 510(K)
K
98
1521
AIA-PACK TPOAB ASSAY
2
Cleared 510(K)
K
98
1930
UNICAP THYROID PEROXIDASE IGG
2
Cleared 510(K)
K
98
1559
UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY
2
Cleared 510(K)
K
98
0206
IMMULITE ANTI-TG AB
2
Cleared 510(K)
K
97
2190
THYROGLOBULIN ASSAY SYSTEM
2
Cleared 510(K)
K
96
3695
IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ
2
Cleared 510(K)
K
96
0369
THYROID PEROXIDASE ANTIBODY ELISA
2
Cleared 510(K)
K
96
0370
THYROGLOBULIN ANTIBODY ELISA
2
Cleared 510(K)
K
95
2183
DIASTAT ANTI-THYROGLOBULIN KIT
2
Cleared 510(K)
K
95
1487
DIASTAT ANTI-THYROID PEROXIDASE KIT
2
Cleared 510(K)
K
95
2129
ORGENTEC ANTI-TPO ELISA
2
Cleared 510(K)
K
95
2130
ORGENTEC ANTI-TG ELISA
2
Cleared 510(K)
K
95
0217
ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY)
2
Cleared 510(K)
K
95
0088
ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)
2
Cleared 510(K)
K
95
0090
ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY)
2
Cleared 510(K)
K
95
0089
ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY)
2
Cleared 510(K)
K
93
1311
THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT
2
Cleared 510(K)
K
93
0485
QUANTA LITE(TM) THYROID M ELISA
2
Cleared 510(K)
K
93
0274
THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME
2
Cleared 510(K)
K
92
5194
THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT
2
Cleared 510(K)
K
92
5826
ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA
2
Cleared 510(K)
K
92
5785
AUTOSTAT ANTI-THYROID MICROSOMAL KIT
2
Cleared 510(K)
K
92
5784
AUTOSTAT ANTITHYROGLOBIN
2
Cleared 510(K)
K
92
5922
ELIAS TGAB
2
Cleared 510(K)
K
92
5923
ELIAS TMAB
2
Cleared 510(K)
K
91
5135
SYNELISA TGAB/TMAB
2
Cleared 510(K)
K
91
5134
SYNELISA TGAB
2
Cleared 510(K)
K
91
5133
SYNELISA TMAB
2
Cleared 510(K)
K
91
5429
KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT
2
Cleared 510(K)
K
91
5428
KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT
2
Cleared 510(K)
K
90
5485
IMMUNOWELL THYROGLOBULIN TEST
2
Cleared 510(K)
K
90
4224
NOVA LITE TM THYROID
2
Cleared 510(K)
K
89
4364
MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)
2
Cleared 510(K)
K
89
4203
ANTI-THYROGLOBULIN TEST KIT
2
Cleared 510(K)
K
88
1933
KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST
2
Cleared 510(K)
K
87
1193
I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT
2
Cleared 510(K)
K
86
5053
SERA-TEK MICROSOMAL ANTIBODY TEST
2
Cleared 510(K)
K
86
3006
125-I TSH RECEPTOR ANTIBODY KIT
2
Cleared 510(K)
K
84
3343
MEDICA IIF-ANTI-THYROID ANTIBODY TEST
2
Cleared 510(K)
K
84
1580
TSH RECEPTOR ANTIBODY KIT 125I TSH
2
Cleared 510(K)
K
82
1489
CORDIA TG
2
Cleared 510(K)
K
81
0982
ANTITHYROID ANTIBODY IMMUNOFLUORESCENT
2
Cleared 510(K)
K
79
1458
AGGLUTINOTEST-THYROGLOBULIN
2
Cleared 510(K)
K
76
0154
TEST, (IVDP) THYROID ANTIBODY
2
Cleared 510(K)
KHT
Fraction V, Antigen, Antiserum, Control
1
Product Code
KTL
Anti-Dna Indirect Immunofluorescent Solid Phase
2
Product Code
KTM
C3-Indirect Immunofluorescent Solid Phase
2
Product Code
KTO
Reagent, Immunoassay, Igg
1
Product Code
KTP
Complement C3b Activator Immunoassay Reagents
2
Product Code
KTS
Second Antibody (Species Specific Anti-Animal Gamma Globulin)
2
Product Code
LJM
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
2
Product Code
LKJ
Antinuclear Antibody, Antigen, Control
2
Product Code
LKL
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
1
Product Code
LKO
Anti-Rnp Antibody, Antigen And Control
2
Product Code
LKP
Anti-Sm Antibody, Antigen And Control
2
Product Code
LLL
Extractable Antinuclear Antibody, Antigen And Control
2
Product Code
LRM
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
2
Product Code
LSW
Anti-Dna Antibody, Antigen And Control
2
Product Code
MGA
Alpha-1 Microglobulin, Antigen, Antiserum, Control
1
Product Code
MID
System, Test, Anticardiolipin Immunological
2
Product Code
MLE
Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
2
Product Code
MLH
Strip, Hama Igg, Elisa, In Vitro Test System
2
Product Code
MOB
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
2
Product Code
MQA
Anti-Ribosomal P Antibodies
2
Product Code
MST
Antibodies, Gliadin
2
Product Code
MSV
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
2
Product Code
MVE
Biosensor, Immunoassay, Myoglobin
2
Product Code
MVJ
Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
2
Product Code
MVM
Autoantibodies, Endomysial(Tissue Transglutaminase)
2
Product Code
NBO
Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)
2
Product Code
NBS
Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
2
Product Code
NBT
Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
2
Product Code
NHX
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
2
Product Code
NIY
Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
2
Product Code
NJF
Antibodies, Anti-Actin, Anti-Smooth Muscle
2
Product Code
NOE
Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
2
Product Code
NPH
Antigen, Cartilage Oligomeric Matrix Protein (Comp)
2
Product Code
NQD
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
2
Product Code
NRI
Autoantibodies, Nuclear Pore Glycoprotein Gp210
2
Product Code
NRX
Complement 4d (C4d) And Complement Receptor 1 (Cr1)
2
Product Code
NST
Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking
2
Product Code
NUM
Autoantibodies, Nuclear Body Protein, Sp100
2
Product Code
NWG
Autoantibodies, Glutamic Acid Decarboxylase (Gad)
2
Product Code
NXO
Calprotectin, Fecal
2
Product Code
NYO
Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
2
Product Code
OBE
Anti-Ss-A 52 Autoantibodies
2
Product Code
OBZ
Alpha-1-Antitrypsin Kit, Qualitative Phenotype
2
Product Code
OCN
Insulin Autoantibody Kit
2
Product Code
OEG
Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
2
Product Code
OIF
Tyrosine Phosphatase (Ia-2) Autoantibody Assay
2
Product Code
OKM
Antibodies, Outer-Membrane Proteins
2
Product Code
OPN
Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex
2
Product Code
OPX
Immunoglobulin A Kappa Heavy & Light Chain Combined
2
Product Code
OPY
Igal Heavy & Light Chain Combined
2
Product Code
OQZ
Anti-Mutated Citrullinated Vimentin Igg
2
Product Code
OSK
Anti-Glutamate Receptor (Type Nmda) Ifa
2
Product Code
OYL
Tryptase Assay System
2
Product Code
PAF
Voltage Gated Calcium Channel (Vgcc) Antibody Assay
2
Product Code
PCG
21-Hydroxylase Antibody (21-Ohab)
2
Product Code
PCN
Immunoglobulin G Kappa Heavy And Light Chain Combined
2
Product Code
PCO
Immunoglobulin G Lambda Heavy And Light Chain Combined
2
Product Code
PDE
Immunoglobulin M Kappa Heavy And Light Chain Combined
2
Product Code
PDF
Immunoglobulin M Lambda Heavy And Light Chain Combined
2
Product Code
PET
Anti-Ss-A Ro60 Autoantibodies
2
Product Code
PHF
Zinc Transporter 8 Auto-Antibody
2
Product Code
PJI
Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
2
Product Code
PNI
Aquaporin-4 Autoantibody
2
Product Code
PTA
Genetic Variant Detection And Health Risk Assessment System
2
Product Code
PUW
System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens
2
Product Code
PZH
Serpina1 Variant Detection System
2
Product Code
QAT
Brain Trauma Assessment Test
2
Product Code
NZB
Quality Control Material, Genetics, Dna
2
Product Code
QUK
Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test
2
Product Code
Subpart G—Tumor Associated Antigen immunological Test Systems
CFR Sub-Part
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 23 May 2025 at 11:06 pm
IM
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subpart-f—immunological-test-systems
/
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K960370
View Source
THYROGLOBULIN ANTIBODY ELISA
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K960370
510(k) Type
Traditional
Applicant
IMMCO DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/20/1996
Days to Decision
147 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Miscellaneous
Subpart C—Clinical Laboratory Instruments
Subpart C—Microbiology Devices
Subpart D—Clinical Toxicology Test Systems
Subpart D—Serological Reagents
Subpart E—Immunology Laboratory Equipment and Reagents
Subpart E—Specimen Preparation Reagents
Subpart F—Automated and Semi-Automated Hematology Devices
Subpart F—Immunological Test Systems
CZQ
Bence-Jones Protein, Antigen, Antiserum, Control
CZR
Hemopexin, Rhodamine, Antigen, Antiserum, Control
CZS
Retinol-Binding Protein, Antigen, Antiserum, Control
CZT
Hemopexin, Fitc, Antigen, Antiserum, Control
CZW
Complement C3, Antigen, Antiserum, Control
CZX
Hemopexin, Antigen, Antiserum, Control
CZY
Complement C1s, Antigen, Antiserum, Control
CZZ
Haptoglobin, Rhodamine, Antigen, Antiserum, Control
DAB
Haptoglobin, Fitc, Antigen, Antiserum, Control
DAC
Complement C3b Activator, Antigen, Antiserum, Control
DAD
Haptoglobin, Antigen, Antiserum, Control
DAE
Complement C9, Antigen, Antiserum, Control
DAF
Gamma Globulin, Fitc, Antigen, Antiserum, Control
DAG
Complement C8, Antigen, Antiserum, Control
DAH
Gamma Globulin, Antigen, Antiserum, Control
DAI
Complement C1r, Antigen, Antiserum, Control
DAJ
Free Secretory Component, Antigen, Antiserum, Control
DAK
Complement C1q, Antigen, Antiserum, Control
DAL
Fraction Iv-5, Antigen, Antiserum, Control
DAM
Hemoglobin, Chain Specific, Antigen, Antiserum, Control
DAN
Fibrinopeptide A, Antigen, Antiserum, Control
DAO
Igm (Mu Chain Specific), Antigen, Antiserum, Control
DAQ
Igg (Fd Fragment Specific), Antigen, Antiserum, Control
DAS
Igg (Fc Fragment Specific), Antigen, Antiserum, Control
CFF
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
CFN
Method, Nephelometric, Immunoglobulins (G, A, M)
CFQ
Radioimmunoassay, Immunoglobulins (G, A, M)
CGM
Method, Immunodiffusion, Immunoglobulins (G, A, M)
CHN
Immunochemical, Ceruloplasmin
CZJ
Igd, Antigen, Antiserum, Control
CZK
Iga, Rhodamine, Antigen, Antiserum, Control
CZL
Iga, Peroxidase, Antigen, Antiserum, Control
CZM
Iga, Ferritin, Antigen, Antiserum, Control
CZN
Iga, Fitc, Antigen, Antiserum, Control
CZO
Inter-Alpha Trypsin Inhibitor, Antigen, Antiserum, Control
CZP
Iga, Antigen, Antiserum, Control
DAW
Alpha-2-Ap-Glycoprotein, Antigen, Antiserum, Control
DAY
Complement C5, Antigen, Antiserum, Control
DBA
Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
DBC
Alpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control
DBE
Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
DBF
Ferritin, Antigen, Antiserum, Control
DBH
Fc, Rhodamine, Antigen, Antiserum, Control
DBI
Complement C4, Antigen, Antiserum, Control
DBJ
Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
DBK
Fc, Fitc, Antigen, Antiserum, Control
DBL
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
DBM
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
DBN
Fc, Antigen, Antiserum, Control
DBY
Fab, Rhodamine, Antigen, Antiserum, Control
DCB
Fab, Fitc, Antigen, Antiserum, Control
DCE
Fab, Antigen, Antiserum, Control
DCF
Albumin, Antigen, Antiserum, Control
DCH
System, Test, C-Reactive Protein, Rhodamine
DCJ
Beta-Globulin, Antigen, Antiserum, Control
DCK
C-Reactive Protein, Antigen, Antiserum, And Control
DCN
System, Test, C-Reactive Protein
DCO
Alpha-Globulin, Antigen, Antiserum, Control
DCT
Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control
DCY
Ceruloplasmin, Fitc, Antigen, Antiserum, Control
DDB
Ceruloplasmin, Antigen, Antiserum, Control
DDC
Thyroglobulin, Antigen, Antiserum, Control
DDD
Transferrin, Rhodamine, Antigen, Antiserum, Control
DDG
Transferrin, Antigen, Antiserum, Control
DDI
Transferrin, Fitc, Antigen, Antiserum, Control
DDJ
Thyroglobulin, Fitc, Antigen, Antiserum, Control
DDK
Beta-2-Glycoprotein Iii, Antigen, Antiserum, Control
DDL
Thyroglobulin, Rhodamine, Antigen, Antiserum, Control
DDN
Beta-2-Glycoprotein I, Antigen, Antiserum, Control
DDO
Myoglobin, Rhodamine, Antigen, Antiserum, Control
DDR
Myoglobin, Antigen, Antiserum, Control
DDS
Prealbumin, Fitc, Antigen, Antiserum, Control
DDT
Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control
DDY
Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control
DDZ
Albumin, Fitc, Antigen, Antiserum, Control
DEA
Myoglobin, Fitc, Antigen, Antiserum, Control
DEB
Alpha-2-Macroglobulin, Antigen, Antiserum, Control
DEC
Inter-Alpha Trypsin Inhibitor, Fitc, Antigen, Antiserum, Control
DEF
Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control
DEG
Lactoferrin, Antigen, Antiserum, Control
DEH
Lambda, Antigen, Antiserum, Control
DEI
Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control
DEJ
Alpha-2-Glycoproteins, Antigen, Antiserum, Control
DEK
Kappa, Rhodamine, Antigen, Antiserum, Control
DEL
Lipoprotein X, Antigen, Antiserum, Control
DEM
Alpha-1-Antitrypsin, Antigen, Antiserum, Control
DEN
Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control
DEO
Kappa, Fitc, Antigen, Antiserum, Control
DER
Alpha-1-Lipoprotein, Antigen, Antiserum, Control
DES
Lambda, Fitc, Antigen, Antiserum, Control
DET
Lactic Dehydrogenase, Antigen, Antiserum, Control
DEW
Igg, Antigen, Antiserum, Control
DEX
Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control
DEZ
Igm, Rhodamine, Antigen, Antiserum, Control
DFB
Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control
DFC
Lipoprotein, Low-Density, Antigen, Antiserum, Control
DFF
Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control
DFG
Lambda, Rhodamine, Antigen, Antiserum, Control
DFH
Kappa, Antigen, Antiserum, Control
DFI
Total Spinal-Fluid, Antigen, Antiserum, Control
DFJ
Albumin, Rhodamine, Antigen, Antiserum, Control
DFK
Igg (Fab Fragment Specific), Antigen, Antiserum, Control
DFL
Igm, Ferritin, Antigen, Antiserum, Control
DFM
Ige, Ferritin, Antigen, Antiserum, Control
DFO
Igg, Rhodamine, Antigen, Antiserum, Control
DFQ
Sperm, Antigen, Antiserum, Control
DFS
Igm, Fitc, Antigen, Antiserum, Control
DFT
Igm, Antigen, Antiserum, Control
DFX
Sperm, Fitc, Antigen, Antiserum, Control
DFZ
Igg (Gamma Chain Specific), Antigen, Antiserum, Control
DGA
Cohn Fraction Ii, Antigen, Antiserum, Control
DGC
Ige, Antigen, Antiserum, Control
DGD
Igg, Ferritin, Antigen, Antiserum, Control
DGE
Igd, Rhodamine, Antigen, Antiserum, Control
DGG
Igd, Fitc, Antigen, Antiserum, Control
DGI
Breast Milk, Rhodamine, Antigen, Antiserum, Control
DGJ
Colostrum, Antigen, Antiserum, Control
DGK
Igg, Fitc, Antigen, Antiserum, Control
DGL
Ige, Rhodamine, Antigen, Antiserum, Control
DGM
Breast Milk, Antigen, Antiserum, Control
DGN
Breast Milk, Fitc, Antigen, Antiserum, Control
DGP
Ige, Fitc, Antigen, Antiserum, Control
DGW
System, Test, Hypersensitivity Pneumonitis
DGX
Ng1m(A), Antigen, Antiserum, Control
DHB
System, Test, Radioallergosorbent (Rast) Immunological
DHC
System, Test, Systemic Lupus Erythematosus
DHI
Ng3m(Bo), Antigen, Antiserum, Control
DHN
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
DHQ
Ng3m(G), Antigen, Antiserum, Control
DHR
System, Test, Rheumatoid Factor
DHY
Ng4m(A), Antigen, Antiserum, Control
JFQ
P-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin
JFR
Indirect Copper Assay, Ceruloplasmin
JHR
Radioimmunoassay, Immunoglobulins (D, E)
JKM
Immunochemical, Bence-Jones Protein
JNL
Immunochemical, Thyroglobulin Autoantibody
JNM
Immunochemical, Transferrin
JZG
System, Test, Beta-2-Microglobulin Immunological
JZH
Factor B, Antigen, Antiserum, Control
JZJ
Prealbumin, Antigen, Antiserum, Control
JZO
System, Test, Thyroid Autoantibody
K
24
0469
Access TPO Antibody
K
21
3517
Access Thyroglobulin Antibody II
K
22
2610
Elecsys Anti-Tg
K
19
3313
Elecsys Anti-TSHR
K
15
1799
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
K
15
2061
IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
K
09
2229
THYRETAIN TM TSI REPORTER BIOASSAY
K
09
0760
THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
K
08
3391
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
K
08
0092
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
K
08
0159
KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT
K
06
1794
FIDIS TM THYRO, MODEL MX002
K
05
2407
ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
K
06
1382
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
K
05
2308
ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
K
05
3426
ROCHE ELECSYS ANTI-TG
K
05
1890
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
K
03
3977
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
K
03
3454
BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN
K
03
2134
TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT
K
02
3593
SERAQUEST ANTI-THYROID PEROXIDASE (TPO)
K
02
0672
ELECSYS ANTI-TG TEST SYSTEM
K
02
0687
DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300
K
02
0349
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS
K
02
0348
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS
K
01
2777
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
K
01
1082
TPO IGG ANTIBODY EIA TEST
K
01
1415
ALPCO MILENIA ANTI-TG EIA
K
01
1201
ALPCO MILENIA ANTI-TPO ELISA
K
00
3291
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY
K
00
3414
VARELISA TG (THYROGLOBULIN) ANTIBODIES,
K
00
0155
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
K
00
0286
BRAHMS DIAGNOSTICA LUMITEST ANTI-TG
K
00
0287
BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO
K
00
0362
MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM
K
99
3585
VARELISA TPO ANTIBODIES, MODEL 12348/12396
K
99
2791
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO
K
99
2790
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG
K
99
1096
IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06
K
99
1094
IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6
K
98
4228
IS ANTI-TPO IGG ELISA TEST SYSTEM
K
98
4165
ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT
K
98
4163
ANTI-TPO EIA DIAGNOSTIC TEST KIT
K
98
3992
NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY
K
98
3553
ANTI-TG IGG ELISA TEST SYSTEM
K
98
2866
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521
K
98
1522
AIA-PACK TGAB ASSAY
K
98
1521
AIA-PACK TPOAB ASSAY
K
98
1930
UNICAP THYROID PEROXIDASE IGG
K
98
1559
UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY
K
98
0206
IMMULITE ANTI-TG AB
K
97
2190
THYROGLOBULIN ASSAY SYSTEM
K
96
3695
IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ
K
96
0369
THYROID PEROXIDASE ANTIBODY ELISA
K
96
0370
THYROGLOBULIN ANTIBODY ELISA
K
95
2183
DIASTAT ANTI-THYROGLOBULIN KIT
K
95
1487
DIASTAT ANTI-THYROID PEROXIDASE KIT
K
95
2129
ORGENTEC ANTI-TPO ELISA
K
95
2130
ORGENTEC ANTI-TG ELISA
K
95
0217
ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY)
K
95
0088
ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)
K
95
0090
ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY)
K
95
0089
ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY)
K
93
1311
THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT
K
93
0485
QUANTA LITE(TM) THYROID M ELISA
K
93
0274
THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME
K
92
5194
THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT
K
92
5826
ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA
K
92
5785
AUTOSTAT ANTI-THYROID MICROSOMAL KIT
K
92
5784
AUTOSTAT ANTITHYROGLOBIN
K
92
5922
ELIAS TGAB
K
92
5923
ELIAS TMAB
K
91
5135
SYNELISA TGAB/TMAB
K
91
5134
SYNELISA TGAB
K
91
5133
SYNELISA TMAB
K
91
5429
KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT
K
91
5428
KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT
K
90
5485
IMMUNOWELL THYROGLOBULIN TEST
K
90
4224
NOVA LITE TM THYROID
K
89
4364
MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)
K
89
4203
ANTI-THYROGLOBULIN TEST KIT
K
88
1933
KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST
K
87
1193
I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT
K
86
5053
SERA-TEK MICROSOMAL ANTIBODY TEST
K
86
3006
125-I TSH RECEPTOR ANTIBODY KIT
K
84
3343
MEDICA IIF-ANTI-THYROID ANTIBODY TEST
K
84
1580
TSH RECEPTOR ANTIBODY KIT 125I TSH
K
82
1489
CORDIA TG
K
81
0982
ANTITHYROID ANTIBODY IMMUNOFLUORESCENT
K
79
1458
AGGLUTINOTEST-THYROGLOBULIN
K
76
0154
TEST, (IVDP) THYROID ANTIBODY
KHT
Fraction V, Antigen, Antiserum, Control
KTL
Anti-Dna Indirect Immunofluorescent Solid Phase
KTM
C3-Indirect Immunofluorescent Solid Phase
KTO
Reagent, Immunoassay, Igg
KTP
Complement C3b Activator Immunoassay Reagents
KTS
Second Antibody (Species Specific Anti-Animal Gamma Globulin)
LJM
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
LKJ
Antinuclear Antibody, Antigen, Control
LKL
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
LKO
Anti-Rnp Antibody, Antigen And Control
LKP
Anti-Sm Antibody, Antigen And Control
LLL
Extractable Antinuclear Antibody, Antigen And Control
LRM
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
LSW
Anti-Dna Antibody, Antigen And Control
MGA
Alpha-1 Microglobulin, Antigen, Antiserum, Control
MID
System, Test, Anticardiolipin Immunological
MLE
Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
MLH
Strip, Hama Igg, Elisa, In Vitro Test System
MOB
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
MQA
Anti-Ribosomal P Antibodies
MST
Antibodies, Gliadin
MSV
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
MVE
Biosensor, Immunoassay, Myoglobin
MVJ
Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
MVM
Autoantibodies, Endomysial(Tissue Transglutaminase)
NBO
Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)
NBS
Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
NBT
Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
NHX
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
NIY
Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
NJF
Antibodies, Anti-Actin, Anti-Smooth Muscle
NOE
Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
NPH
Antigen, Cartilage Oligomeric Matrix Protein (Comp)
NQD
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
NRI
Autoantibodies, Nuclear Pore Glycoprotein Gp210
NRX
Complement 4d (C4d) And Complement Receptor 1 (Cr1)
NST
Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking
NUM
Autoantibodies, Nuclear Body Protein, Sp100
NWG
Autoantibodies, Glutamic Acid Decarboxylase (Gad)
NXO
Calprotectin, Fecal
NYO
Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
OBE
Anti-Ss-A 52 Autoantibodies
OBZ
Alpha-1-Antitrypsin Kit, Qualitative Phenotype
OCN
Insulin Autoantibody Kit
OEG
Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
OIF
Tyrosine Phosphatase (Ia-2) Autoantibody Assay
OKM
Antibodies, Outer-Membrane Proteins
OPN
Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex
OPX
Immunoglobulin A Kappa Heavy & Light Chain Combined
OPY
Igal Heavy & Light Chain Combined
OQZ
Anti-Mutated Citrullinated Vimentin Igg
OSK
Anti-Glutamate Receptor (Type Nmda) Ifa
OYL
Tryptase Assay System
PAF
Voltage Gated Calcium Channel (Vgcc) Antibody Assay
PCG
21-Hydroxylase Antibody (21-Ohab)
PCN
Immunoglobulin G Kappa Heavy And Light Chain Combined
PCO
Immunoglobulin G Lambda Heavy And Light Chain Combined
PDE
Immunoglobulin M Kappa Heavy And Light Chain Combined
PDF
Immunoglobulin M Lambda Heavy And Light Chain Combined
PET
Anti-Ss-A Ro60 Autoantibodies
PHF
Zinc Transporter 8 Auto-Antibody
PJI
Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
PNI
Aquaporin-4 Autoantibody
PTA
Genetic Variant Detection And Health Risk Assessment System
PUW
System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens
PZH
Serpina1 Variant Detection System
QAT
Brain Trauma Assessment Test
NZB
Quality Control Material, Genetics, Dna
QUK
Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test
Subpart G—Tumor Associated Antigen immunological Test Systems
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
IM
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subpart-f—immunological-test-systems
/
JZO
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K960370
View Source
THYROGLOBULIN ANTIBODY ELISA
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K960370
510(k) Type
Traditional
Applicant
IMMCO DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/20/1996
Days to Decision
147 days
Submission Type
Statement