Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- CDNUrease, Photometric, Urea Nitrogen2Product Code
- CDOAcid, Uric, Uricase (U.V.)1Product Code
- CDPRadioimmunoassay, Total Triiodothyronine2Product Code
- CDEChromatographic Separation/Zimmerman, 17-Ketosteroids1Product Code
- CHARadioimmunoassay, Corticosterone1Product Code
- CDFAcid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin1Product Code
- CDGChromatography Separation/Zimmerman 17-Ketogenic Steroids1Product Code
- CDHAcid, Uric, Phosphotungstate Reduction1Product Code
- CDKAcid, Vanilmandelic, Electrophoretic Separation1Product Code
- CDLBerthelot Indophenol, Urea Nitrogen2Product Code
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)1Product Code
- CCYZimmerman (Spectrophotometric), 17-Ketosteroids1Product Code
- CCZZimmerman/Norymberski, 17-Ketogenic Steroids1Product Code
- CDAAcid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin1Product Code
- CDBPorter Silber Hydrazone, 17-Hydroxycorticosteroids1Product Code
- CDCL-Leucyl B-Naphthylamide, Leucine Aminopeptidase1Product Code
- CDDRadioassay, Vitamin B122Product Code
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen2Product Code
- CDR1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine1Product Code
- CDSElectrode, Ion Specific, Urea Nitrogen2Product Code
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides1Product Code
- CDWDiacetyl-Monoxime, Urea Nitrogen2Product Code
- CDXRadioimmunoassay, Total Thyroxine2Product Code
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone1Product Code
- CEATlc Chromatographic Separation Triglycerides1Product Code
- CECRadioimmunoassay, Free Thyroxine2Product Code
- CED5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase1Product Code
- CEERadioimmunoassay, Thyroxine-Binding Globulin2Product Code
- CEFElectrophoretic, Protein Fractionation1Product Code
- CEIUranyl Acetate/Zinc Acetate, Sodium2Product Code
- CEJTetraphenyl Borate, Colorimetry, Potassium2Product Code
- CEKBiuret (Colorimetric), Total Protein2Product Code
- CELAmmonium Molybdate And Ammonium Vanadate, Phospholipids1Product Code
- CEMElectrode, Ion Specific, Potassium2Product Code
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)1Product Code
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus1Product Code
- CEPRadioimmunoassay, Luteinizing Hormone1Product Code
- CEQMolybdenum Blue Method, Phospholipids1Product Code
- CER2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase2Product Code
- CESChromogenesis, Phenylketones (Urinary, Non-Quant.)1Product Code
- CETOlive Oil Emulsion (Turbidimetric), Lipase1Product Code
- CEWRadioimmunoassay, Parathyroid Hormone2Product Code
- CEXChromatographic Separation, Lactate Dehydrogenase Isoenzymes2Product Code
- CFAElectrode, Ion Specific, Magnesium1Product Code
- CFBChromatographic Derivative, Total Lipids1Product Code
- CFDSulfophosphovanillin, Colorimetry, Total Lipids1Product Code
- CFEElectrophoretic, Lactate Dehydrogenase Isoenzymes2Product Code
- CFGOil Emulsion/Thymolphthalein (Titrimetric), Lipase1Product Code
- CFHTetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase2Product Code
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase2Product Code
- CFLRadioimmunoassay, Human Growth Hormone1Product Code
- CFMBathophenanthroline, Colorimetry, Iron (Non-Heme)1Product Code
- CFOTitrimetric, Magnesium1Product Code
- CFPRadioimmunoassay, Immunoreactive Insulin1Product Code
- CFRHexokinase, Glucose2Product Code
- CFTRadioimmunoassay, Prolactin (Lactogen)1Product Code
- CFWCopper Reduction, Glucose2Product Code
- CGAGlucose Oxidase, Glucose2Product Code
- CGCRadioimmunoassay, Gastrin1Product Code
- CGDFerricyanide, Glucose2Product Code
- CGEOrthotoluidine, Glucose2Product Code
- CGFRadioimmunoassay, Estrone1Product Code
- CGHElectrophoretic, Globulin1Product Code
- CGIRadioimmunoassay, Estriol1Product Code
- CGJRadioimmunoassay, Follicle-Stimulating Hormone1Product Code
- CGLElectrode, Ion Based, Enzymatic, Creatinine2Product Code
- CGNAcid, Folic, Radioimmunoassay2Product Code
- CGOLieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol1Product Code
- CGRRadioimmunoassay, Cortisol2Product Code
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes2Product Code
- CGTRadioimmunoassay, Cyclic Gmp2Product Code
- CGXAlkaline Picrate, Colorimetry, Creatinine2Product Code
- CGZElectrode, Ion-Specific, Chloride2Product Code
- CHCTitrimetric Permanganate And Bromophenol Blue, Calcium2Product Code
- CHDAcid, Ferric Ion-Sulfuric, Cholesterol1Product Code
- CHERadioimmunoassay, Corticoids1Product Code
- CHGAcid, Phosphoric-Tungstic (Spectrophotometric), Chloride2Product Code
- CHHEnzymatic Esterase--Oxidase, Cholesterol1Product Code
- CHILipase-Esterase, Enzymatic, Photometric, Lipase1Product Code
- CHJMercuric Thiocyanate, Colorimetry, Chloride2Product Code
- CHKMercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride2Product Code
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph2Product Code
- CHMRadioimmunoassay, Total Estrogens In Pregnancy1Product Code
- CHORadioimmunoassay, Cyclic Amp2Product Code
- CHPRadioimmunoassay, Estradiol1Product Code
- CHQChromatographic/Fluorometric Method, Catecholamines1Product Code
- CHRTitrimetric Phenol Red, Carbon-Dioxide2Product Code
- CHSCoulometric Method, Carbon-Dioxide2Product Code
- CHTElectrophoretic Method, Catecholamines1Product Code
- CHWTitrimetric With Edta And Indicator, Calcium2Product Code
- CHZDi (O-Hydroxyphenylimine) Ethane, Calcium2Product Code
- CIAMethylthymol Blue, Calcium2Product Code
- CIBRadioimmunoassay, Angiotensin I And Renin2Product Code
- CICCresolphthalein Complexone, Calcium2Product Code
- CIDAlizarin Sulfonate, Calcium2Product Code
- CIEVolumetric/Manometric, Carbon-Dioxide2Product Code
- CIFVanillin Pyruvate, Ast/Sgot2Product Code
- CIGDiazo Colorimetry, Bilirubin2Product Code
- K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)2Cleared 510(K)
- K222104Atellica® CH Diazo Total Bilirubin (D_TBil)2Cleared 510(K)
- K223324Total Bilirubin22Cleared 510(K)
- K190807VITROS XT Chemistry Products TBIL-ALKP Slides2Cleared 510(K)
- K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+12Cleared 510(K)
- K150510Total Bilirubin2Cleared 510(K)
- K131544COBAS C BILIRUBIN TOTAL GEN.32Cleared 510(K)
- K131217S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN2Cleared 510(K)
- K123802EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT2Cleared 510(K)
- K123965COBAS INTEGRA BILIRUBIN DIRECT GEN.22Cleared 510(K)
- K121985ARCHITECT TOTAL BILIRUBIN2Cleared 510(K)
- K110780ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II2Cleared 510(K)
- K111143POLY-CHEM 90 TOTAL BILIRUBIN2Cleared 510(K)
- K093623GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO2Cleared 510(K)
- K091991EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 102002Cleared 510(K)
- K081193COBAS INTEGRA 400/800 BILIRUBIN TOTAL2Cleared 510(K)
- K082210TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-302Cleared 510(K)
- K080810EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT2Cleared 510(K)
- K080435OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X1812Cleared 510(K)
- K063744COBAS INTEGRA C 1112Cleared 510(K)
- K063543COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 2262Cleared 510(K)
- K061830STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+2Cleared 510(K)
- K061839DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K21252Cleared 510(K)
- K061719DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC2122Cleared 510(K)
- K060325ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P2Cleared 510(K)
- K060574TOTAL BILIRUBIN2Cleared 510(K)
- K060628DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR2Cleared 510(K)
- K050869MODIFICATION TO ABL800 FLEX2Cleared 510(K)
- K051432SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS2Cleared 510(K)
- K040391TOTAL BILIRUBIN REAGENT SET2Cleared 510(K)
- K040631VITALAB DIRECT BILIRUBIN REAGENT2Cleared 510(K)
- K030003ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR2Cleared 510(K)
- K030014ATAC TOTAL BILIRUBIN REAGENT2Cleared 510(K)
- K024116WIENER LAB. BILIRUBINA DIRECT AA2Cleared 510(K)
- K023330BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/302Cleared 510(K)
- K022962WIENER LAB. BILIRRUBINA TOTAL AA2Cleared 510(K)
- K022339TOTAL BILIRUBIN2Cleared 510(K)
- K022180DIRECT BILIRUBIN2Cleared 510(K)
- K011972DIRECT BILIRUBIN REAGENT2Cleared 510(K)
- K003892TOTAL BILIRUBIN REAGENT2Cleared 510(K)
- K003829TOTAL BILIRUBIN2Cleared 510(K)
- K003693DIRECT BILIRUBIN2Cleared 510(K)
- K993867BAYER ADVIA IMS SYSTEM2Cleared 510(K)
- K993771CARESIDE DIRECT BILIRUBIN2Cleared 510(K)
- K991866BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-042Cleared 510(K)
- K991175MODIFICATION TO ALCYON DIRECT BILIRUBIN2Cleared 510(K)
- K983304SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT2Cleared 510(K)
- K983133TBIL2Cleared 510(K)
- K972382UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL2Cleared 510(K)
- K981943DBIL2Cleared 510(K)
- K981883ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 18778442Cleared 510(K)
- K981588CARESIDE TOTAL BILIRUBIN2Cleared 510(K)
- K981632ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT2Cleared 510(K)
- K981609BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-302Cleared 510(K)
- K981336TBIL2Cleared 510(K)
- K981276N-ASSAY L D-BIL2Cleared 510(K)
- K981289N-ASSAY L T-BIL2Cleared 510(K)
- K981222DIRECT BILIRUBIN (DBIL)2Cleared 510(K)
- K974874BILIRUBIN-SL (TOTAL) ASSAY2Cleared 510(K)
- K973109SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT2Cleared 510(K)
- K972716SYNERMED TOTAL BILIRUBIN REAGENT KIT2Cleared 510(K)
- K972073TOTAL BILIRUBIN REAGENT2Cleared 510(K)
- K970986WAKO DIRECT BILIRUBIN V2Cleared 510(K)
- K963939SYNERMED DIRECT BILIRUBIN REAGENT KIT2Cleared 510(K)
- K955880DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-052Cleared 510(K)
- K955940TOTAL BILIRUBIN REAGENT2Cleared 510(K)
- K955300TOTAL BILIRUBIN PROCEDURE2Cleared 510(K)
- K942999BILIRUBIN(TOTAL) QVET2Cleared 510(K)
- K942949BILIRUBIN (DIRECT) QVET2Cleared 510(K)
- K934068BECKMAN DIRECT BILIRUBIN REAGENT2Cleared 510(K)
- K940570SYNERMED TOTAL BILIRUBIN REAGENT KIT2Cleared 510(K)
- K933026SYNERMED DIRECT BILIRUBIN REAGENT KIT2Cleared 510(K)
- K932159SYSTEMATE DIRECT BILIRUBIN CAT. NO. 654062Cleared 510(K)
- K931888TOTAL BILIRUBIN2Cleared 510(K)
- K930679DIRECT BILIRUBIN2Cleared 510(K)
- K924964OLYMPUS TOTAL BILIRUBIN REAGENT2Cleared 510(K)
- K924963OLYMPUS DIRECT BILIRUBIN REAGENT2Cleared 510(K)
- K923609OLYMPUS TOTAL BILIRUBIN REAGENT2Cleared 510(K)
- K923083TOTAL BILIRUBIN CATALOG NO. 654072Cleared 510(K)
- K922856SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 10002Cleared 510(K)
- K923608OLYMPUS DIRECT BILIRUBIN REAGENT2Cleared 510(K)
- K920653IL TEST BILIRUBIN TOTAL/DIRECT2Cleared 510(K)
- K921844KODAK EKTACHEM DT SLIDES (NBIL)2Cleared 510(K)
- K914873DIAZO COLORIMETRY, BILIRUBIN2Cleared 510(K)
- K913466ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A202Cleared 510(K)
- K913307ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A212Cleared 510(K)
- K912733AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT2Cleared 510(K)
- K911866TRACE TOTAL/DIRECT BILIRUBIN REAGENT2Cleared 510(K)
- K910635TOTAL BILIRUBIN REAGENT SET2Cleared 510(K)
- K910593ROCHE REAGENT FOR DIRECT BILIRUBIN2Cleared 510(K)
- K910591ROCHE REAGENT FOR TOTAL BILIRUBIN2Cleared 510(K)
- K904468DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/71762Cleared 510(K)
- K905622COULTER DIRECT BILLRUBIN REAGENT2Cleared 510(K)
- K904381DIAZO COLORIMENTRY DIRECT BILIRUBIN2Cleared 510(K)
- K903728SYNERMED DIRECT BILIRUBIN REAGENT KIT2Cleared 510(K)
- K902801BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT2Cleared 510(K)
- K902328SYNERMED TOTAL BILIRUBIN REAGENT KIT2Cleared 510(K)
- K902199COULTER DIRECT BILIRUBIN2Cleared 510(K)
- K902123SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 654062Cleared 510(K)
- K897174OLYMPUS(TM) TOTAL BILIRUBIN2Cleared 510(K)
- K901266COULTER TOTAL BILIRUBIN REAGENT2Cleared 510(K)
- K900571AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD)2Cleared 510(K)
- K897176SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX2Cleared 510(K)
- K897175OLYMPUS DIRECT BILIRUBIN2Cleared 510(K)
- K900259DIRECT BILIRUBIN REAGENT2Cleared 510(K)
- K896232COBAS READY TOTAL BILIRUBIN REAGENT2Cleared 510(K)
- K895822TOTAL BILIRUBIN L.F.2Cleared 510(K)
- K895119SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 654062Cleared 510(K)
- K895118SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 654072Cleared 510(K)
- K892801CLINISTAT TOTAL BILIRUBIN REAGENT TEST2Cleared 510(K)
- K893730DIRECT BILIRUBIN REAGENT2Cleared 510(K)
- K892668TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS2Cleared 510(K)
- K892905DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.2Cleared 510(K)
- K891240DIRECT BILIRUBIN FOR CONTINUOUS FLOW2Cleared 510(K)
- K891025TOTAL BILIRUBIN FOR CONTINUOUS FLOW2Cleared 510(K)
- K890070TOTAL BILIRUBIN REAGENT, CONCENTRATED2Cleared 510(K)
- K885285DIRECT BILIRUBIN TEST CATALOG NO. SR10082Cleared 510(K)
- K885284TOTAL BILIRUBIN TEST CATALOG NO. SR10072Cleared 510(K)
- K871115UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON.2Cleared 510(K)
- K884224TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS2Cleared 510(K)
- K880437VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM2Cleared 510(K)
- K882459DIAZO, COLORIMETRIC BILIRUBIN2Cleared 510(K)
- K881798TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN2Cleared 510(K)
- K881172BILIRUBIN (DIRECT)2Cleared 510(K)
- K881241TOTAL BILIRUBIN REAGENT2Cleared 510(K)
- K881166DIRECT BILIRUBIN PROCEDURE2Cleared 510(K)
- K880743ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT2Cleared 510(K)
- K880395TOTAL BILIRUBIN PROCEDURE RUN ON A DEMAND INSTRU.2Cleared 510(K)
- K880396TOTAL BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.2Cleared 510(K)
- K880397DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.2Cleared 510(K)
- K875069BILIRUBIN (TOTAL)2Cleared 510(K)
- K874311MULTICHEM (R) TOTAL BILIRUBIN2Cleared 510(K)
- K874261IQ/QCA TOTAL BILIRUBIN2Cleared 510(K)
- K872818REFLOTRON BILIRUBIN2Cleared 510(K)
- K873551CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/952Cleared 510(K)
- K873424EASY-TEST CONJUGATED BILIRUBIN (CBIL) #166902Cleared 510(K)
- K872513EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 166042Cleared 510(K)
- K872512EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/952Cleared 510(K)
- K872487VISION(R) TOTAL BILIRUBIN2Cleared 510(K)
- K870365DIRECT BILIRUBIN REAGENT - ACID DIAZO METHOD2Cleared 510(K)
- K870364TOTAL BILIRUBIN REAGENT - DMSO METHOD2Cleared 510(K)
- K872197PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT2Cleared 510(K)
- K870095BILIRUBIN TESTER2Cleared 510(K)
- K871531REAGENTS 1263,1273,1284,1425,014301,0535832Cleared 510(K)
- K871530TOTAL BILIRUBIN REAGENT 1372,1425,1284,1273,0535832Cleared 510(K)
- K863056BILIRUBIN TOTAL2Cleared 510(K)
- K863265DIRECT BILIRUBIN PROCEDURE2Cleared 510(K)
- K863057BILIRUBIN TOTAL DIRECT2Cleared 510(K)
- K863262TOTAL BILIRUBIN PROCEDURE2Cleared 510(K)
- K863055BILIFAST2Cleared 510(K)
- K862359METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM2Cleared 510(K)
- K862299AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS2Cleared 510(K)
- K861998TOTAL BILIRUBIN TEST KIT2Cleared 510(K)
- K861671DIRECT BILIRUBIN PROCEDURE2Cleared 510(K)
- K861651TOTAL BILIRUBIN PROCEDURE2Cleared 510(K)
- K861413BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET2Cleared 510(K)
- K861095BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-042Cleared 510(K)
- K861094BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-022Cleared 510(K)
- K860424A-GENT LIQUID TOTAL BILIRUBIN2Cleared 510(K)
- K860214TOTAL BILIRUBIN REAGENT SET2Cleared 510(K)
- K855079NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/952Cleared 510(K)
- K860257DIRECT BILIRUBIN2Cleared 510(K)
- K855195DIRECT & TOTAL BILIRUBIN SET2Cleared 510(K)
- K854180IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN2Cleared 510(K)
- K852008T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL2Cleared 510(K)
- K850748I-L TEST, DIRECT BILIRUBIN SET2Cleared 510(K)
- K843908ABBOTT TDT EIA2Cleared 510(K)
- K850901DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE2Cleared 510(K)
- K850379DIRECT BILIRUBIN FOR DEMAND ANALYZER2Cleared 510(K)
- K843329SYSTEMATE D-BILI 672132Cleared 510(K)
- K843328SYSTEMATE T-BILI 672122Cleared 510(K)
- K843178TOTAL BILIRUBIN TEST2Cleared 510(K)
- K843032BILIRUBIN ASSAY KIT - TOTAL2Cleared 510(K)
- K843027BILIRUBIN ASSAY KIT DIRECT2Cleared 510(K)
- K842809TECHNICON RA-1000 SYS, DIRECT BILIRUBIN2Cleared 510(K)
- K842385ACA CONJUGATED BILIRUBIN ANALYTICAL2Cleared 510(K)
- K841892RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT2Cleared 510(K)
- K840757ELVI 444 BILITRON2Cleared 510(K)
- K841572DIRECT BILIRUBIN REAGENT2Cleared 510(K)
- K841050TOTAL BILIRUBIN REAGENT SET2Cleared 510(K)
- K840486TOTAL BILIRUBIN REAGENT2Cleared 510(K)
- K840880EKTACHEM CLINICAL CHEM. SLIDES2Cleared 510(K)
- K840779NEONATAL BILIRUBIN REAGENT2Cleared 510(K)
- K840777DIRECT BILIRUBIN REAGENT2Cleared 510(K)
- K840606EKTACHEM CLINICAL CHEM. SLIDES2Cleared 510(K)
- K840111TOTAL BILIRUBIN2Cleared 510(K)
- K840564LIQUI ZYME TOTAL BILIRUBIN REAGENT2Cleared 510(K)
- K832942TOTAL & DIRECT BILIRUBIN PROCEDURES2Cleared 510(K)
- K832748COMPUR* EASYTOUCH TOTAL BILIRUBIN2Cleared 510(K)
- K833004PARAMAX TOTAL BILIRUBIN REAGENT2Cleared 510(K)
- K832870DIAZO COLORIMETRY, BILLIRUBIN2Cleared 510(K)
- K832357ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK2Cleared 510(K)
- K832236SIGMA PROCEDURE #550 DETERM. BILIRUB2Cleared 510(K)
- K831844DIRECT BILIRUBIN REAGENT2Cleared 510(K)
- K831843GILCHEM TOTAL BILIRUBIN REAGENT2Cleared 510(K)
- K830714TOTAL BILIRUBIN REAGENT2Cleared 510(K)
- K821873ULTRACHEM T-BILI2Cleared 510(K)
- K821197TOTAL BILIRUBIN REAGENT SET2Cleared 510(K)
- K821462ULTRACHEM T-BILI, #649712Cleared 510(K)
- K820714DOW BILIRUBIN(DIRECT) DETERMINATION2Cleared 510(K)
- K820675BILIRUBIN(TOTAL) DETERMINATION CTMS2Cleared 510(K)
- K812841TOTAL & DIRECT BILIRUBIN REAGENT SET2Cleared 510(K)
- K812784BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD2Cleared 510(K)
- K812754BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN2Cleared 510(K)
- K811881KING DIAGNOSTICS TOTAL BILIRUBIN TEST2Cleared 510(K)
- K810055STANBIO BILIRUBIN TEST SET2Cleared 510(K)
- K802630CAFFEINE REAGENT DIAZO COLORIMETRY2Cleared 510(K)
- K802154REAGENTS USED-QUAN. MEASURE OF SERUM2Cleared 510(K)
- K801117COBAS TOTAL BILIRUBIN REAGENT & DILUENT2Cleared 510(K)
- K800686REAGENT FOR DETERM. DIRECT BILIRUBIN2Cleared 510(K)
- K800675REAGENTS FOR DETERM. TOTAL BILIRUBIN2Cleared 510(K)
- K792465CONNECTICUT DIAGNOSTICS, LTS. DIRECT2Cleared 510(K)
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- K771092UNIPAK TOTAL & DIRECT BILIRUBIN2Cleared 510(K)
- K771089UNIPAK TOTAL BILIRUBIN2Cleared 510(K)
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- K770121MANUEL BILIRUBIN REAGENT SET2Cleared 510(K)
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- K760406CAFFEINE DILUENT2Cleared 510(K)
- K760407SULFANILIC ACID2Cleared 510(K)
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- CIZRadioimmunoassay, Androstenedione1Product Code
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- CJLBeta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
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- CJOAlpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
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- CJRAcid Phosphatase, Thymol Blue Monophosphate2Product Code
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- CKCVanillin Pyruvate, Alt/Sgpt1Product Code
- CKDHydrazone Colorimetry, Alt/Sgpt1Product Code
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- CKFPhenylphosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
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- JGXTurbidimetric Method, Triglycerides1Product Code
- JGYColorimetric Method, Triglycerides1Product Code
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- JHERadioassay, 17-Hydroxycorticosteroids1Product Code
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- JHMColorimetric Method, Lipoproteins1Product Code
- JHNTurbidimetric Method, Lipoproteins1Product Code
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- JHPRadial Immunodiffusion, Lipoproteins1Product Code
- JHQNephelometric Method, Lipoproteins1Product Code
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- JHXFluorometric Method, Cpk Or Isoenzymes2Product Code
- JHYColorimetric Method, Cpk Or Isoenzymes2Product Code
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- JIBU.V. Method, Galactose1Product Code
- JICColorimetric Method, Galactose1Product Code
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- JIEMethod, Ion-Exchange, Ammonia1Product Code
- JIFEnzymatic Method, Ammonia1Product Code
- JIGElectrode, Ion-Specific Method, Ammonia1Product Code
- JIJWet Ash Method, Protein-Bound Iodine1Product Code
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- JIMMethod, Metallic Reduction, Glucose (Urinary, Non-Quantitative)2Product Code
- JINNitroprusside, Ketones (Urinary, Non-Quant.)1Product Code
- JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)1Product Code
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)1Product Code
- JISCalibrator, Primary2Product Code
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- JIYPhotometric Method, Iron (Non-Heme)1Product Code
- JIZAtomic Absorption, Iron (Non-Heme)1Product Code
- JJARadio-Labeled Iron Method, Iron (Non-Heme)1Product Code
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)1Product Code
- JJRElectrolyte Controls (Assayed And Unassayed)1Product Code
- JJSControls For Blood-Gases, (Assayed And Unassayed)1Product Code
- JJTEnzyme Controls (Assayed And Unassayed)1Product Code
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- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)1Product Code
- JJYMulti-Analyte Controls, All Kinds (Assayed)1Product Code
- JKATubes, Vials, Systems, Serum Separators, Blood Collection2Product Code
- JKBRadioimmunoassay, Compound S (11-Deoxycortisol)1Product Code
- JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)1Product Code
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- JKLAcid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry1Product Code
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- JKRRadioimmunoassay, Calcitonin2Product Code
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- JKXN-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin1Product Code
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- JKZDiethyldithiocarbamate (Colorimetric), Copper1Product Code
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- JLBAtp And Creatine Kinase (Enzymatic), Creatine1Product Code
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- JLHTitrimetric, Fatty Acids1Product Code
- JLITetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid1Product Code
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- JLKSodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity1Product Code
- JLLTubeless Analysis, Gastric Acidity1Product Code
- JLNChromatographic, Glutathione1Product Code
- JLOEnzymatic (Glutathione Reductase), Glutathione1Product Code
- JLPSpectrophotometric Method, Pregnanediol1Product Code
- JLQSpectrophotometric Method, Pregnanetriol1Product Code
- JLRGas Chromatography, Pregnanetriol1Product Code
- JLSRadioimmunoassay, Progesterone1Product Code
- JLTAcid, Pyruvic, Enzymatic (U.V.)1Product Code
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone2Product Code
- JLXRadioimmunoassay, 17-Hydroxyprogesterone1Product Code
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- JLZNadh, Phosphoglycerate Mutase, Atp (U.V.) 2,3-Diphosphoglyceric Acid1Product Code
- JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)1Product Code
- JMDRadioimmunoassay, Total Estrogens, Nonpregnancy1Product Code
- JMERadioimmunoassay, Glucagon1Product Code
- JMFRadioimmunoassay, Human Placental Lactogen2Product Code
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- JMJMicrobiological, Histidine1Product Code
- JMKAcid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase1Product Code
- JMMColumn Chromatography & Color Development, Hydroxyproline1Product Code
- JMNExtraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline1Product Code
- JMOFerrozine (Colorimetric) Iron Binding Capacity1Product Code
- JMQM. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)1Product Code
- JMRImmunochemical, Lysozyme (Muramidase)1Product Code
- JMSAcid, Oxalacetic And Nadh Oxidation (U.V.), Malic Dehydrogenase1Product Code
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- JMXNinhydrin, Nitrogen (Amino-Nitrogen)1Product Code
- JMYCitrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase1Product Code
- JMZComparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality1Product Code
- JNAVapor Pressure, Osmolality Of Serum & Urine1Product Code
- JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine2Product Code
- JNCColumn Or Paper Chromatography Plus Ninhydrin, Phenylalanine2Product Code
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- JNFIon-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen1Product Code
- JNGRadioimmunoassay, Pregnenolone1Product Code
- JNJPhosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase1Product Code
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- JNON-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin1Product Code
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- JNTChromatographic, Phospholipids1Product Code
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- JQBKinetic Method, Gamma-Glutamyl Transpeptidase1Product Code
- JQDResin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity1Product Code
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- JQFBathophenanthroline, Iron Binding Capacity1Product Code
- JQGRadiometric, Fe59, Iron Binding Capacity1Product Code
- JQHTrinitrobenzene Sulfonate (Spectroscopic), Nitrogen (Amino-Nitrogen)1Product Code
- JQIRotating Disc, Plasma Viscometry1Product Code
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- JQNColorimetric, Mucopolysaccharides1Product Code
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- KHPAcid, Lactic, Enzymatic Method1Product Code
- KHQRadioassay, Triiodothyronine Uptake2Product Code
- KHSEnzymatic, Carbon-Dioxide2Product Code
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine2Product Code
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- KMSPhenolphthalein Colorimetry, Carbon-Dioxide2Product Code
- KNKAcid, Uric, Uricase (Colorimetric)1Product Code
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- KQPFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase2Product Code
- KWWRadioimmunoassay, Cholyglycine, Bile Acids2Product Code
- KWXRadioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids2Product Code
- LBRLdl & Vldl Precipitation, Hdl1Product Code
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl1Product Code
- LBTElectrophoresis, Cholesterol Via Esterase-Oxidase, Hdl1Product Code
- LCHTonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical1Product Code
- LCXKit, Test, Pregnancy, Hcg, Over The Counter2Product Code
- LFPConductivity Rate, Urea Nitrogen2Product Code
- LFQAcid, Uric, Acid Reduction Of Ferric Ion1Product Code
- LFRGlucose Dehydrogenase, Glucose2Product Code
- LFSRadioreceptor Assay, Human Chorionic Gonadotropin2Product Code
- LIGRadioassay, Intrinsic Factor Blocking Antibody2Product Code
- LPSUrinary Homocystine (Nonquantitative) Test System2Product Code
- LPTSystem, Test, Urinary Methylmalonic Acid2Product Code
- LPWSystem, Test, Oxalate1Product Code
- MMIImmunoassay Method, Troponin Subunit2Product Code
- MPGUrinary Carbohydrate Analysis Kit1Product Code
- MQMBilirubin (Total And Unbound) In The Neonate Test System1Product Code
- MRGSystem, Test, Vitamin D2Product Code
- MRRSystem, Test, Low Density, Lipoprotein1Product Code
- MRVDrink, Glucose Tolerance2Product Code
- MSJApolipoproteins1Product Code
- MSMSystem, Test, Lipoprotein(A)1Product Code
- MYTBiosensor, Immunoassay, Cpk Or Isoenzymes2Product Code
- MZUSystem, Test, Sodium, Enzymatic Method2Product Code
- MZVTest, System, Potassium, Enzymatic Method2Product Code
- NAKSystem, Test, Biotinidase2Product Code
- NALTest, Immunoassay, Biosensor, Hcg2Product Code
- NAOTest, Carbohydrate Deficient Transferrin1Product Code
- NAQLipoprotein, High Density, Hdl, Over The Counter1Product Code
- NBCTest, Natriuretic Peptide2Product Code
- NBWSystem, Test, Blood Glucose, Over The Counter2Product Code
- NDREnzyme Immunoassay, Inhibin-A1Product Code
- NDYTest, Cystatin C2Product Code
- NEOSystem, Test, Osteocalcin2Product Code
- NHGEnzyme Immunoassay, Cortisol, Salivary2Product Code
- NJVTest, Albumin Cobalt Binding2Product Code
- NQLSystem, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry2Product Code
- NQMImmunoassay For Detection Of Amniotic Fluid Protein(S).1Product Code
- NRHSystem, Breath Measurement1Product Code
- OAMImmunoassay, Insulin-Like Growth Factor Binding Protein-11Product Code
- OHQMulti-Analyte Controls Unassayed1Product Code
- OLDInternal Polymerase Chain Reaction Control, Not Assay Specific1Product Code
- ONDOsmolality Of Tears1Product Code
- OSXGalectin-3 In Vitro Diagnostic Assay2Product Code
- OYGSt2 Assay2Product Code
- OYJDna Specimen Collection, Saliva2Product Code
- PDJHemoglobin A1c Test System2Product Code
- PDSAmniotic Fluid Protein Immunoassay1Product Code
- PFQMmp-9 Test System1Product Code
- PIGAcute Kidney Injury Test System2Product Code
- PJCNewborn Screening Specimen Collection Paper2Product Code
- PJDOral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device2Product Code
- PJEBlood/Plasma Collection Device For Dna Testing2Product Code
- PJTContinuous Glucose Monitor Secondary Display2Product Code
- PKUInsulin Pump Secondary Display2Product Code
- PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)2Product Code
- PQTAlpha-L-Iduronidase (Idua) Newborn Screening Test System2Product Code
- PQUAlpha-D-Glucosidase (Gaa) Newborn Screening Test System2Product Code
- PQVß-Glucocerebrosidase (Gba) Newborn Screening Test System2Product Code
- PQWAlpha-D-Galactosidase A (Gla) Newborn Screening Test System2Product Code
- PRJCapillary Blood Collection Device For Alternative Site Collection2Product Code
- PSL25-Oh-Vitamin D Mass Spectrometry Test System2Product Code
- PTCUric Acid Test System For At Home Prescription Use1Product Code
- PYPLow-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test1Product Code
- PYVHospital Continuous Glucose Monitoring System2Product Code
- PZIPrescription Use Blood Glucose Meter For Near-Patient Testing2Product Code
- QBJIntegrated Continuous Glucose Monitoring System, Factory Calibrated2Product Code
- QCCInsulin Pump Therapy Adjustment Calculator For Healthcare Professionals2Product Code
- QCLAcid-Sphingomyelinase (Asm) Newborn Screening Test System2Product Code
- QCMß-Galactocerebrosidase (Galc) Newborn Screening Test System2Product Code
- QDHMenopause Test System2Product Code
- QDKIntegrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management2Product Code
- QDLIntegrated Continuous Glucose Monitoring System For Professional Retrospective Use2Product Code
- QEIBreast Milk Macronutrients Test System2Product Code
- QIIIntegrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use2Product Code
- QJEMuscular Dystrophy Newborn Screening Test2Product Code
- QJIInteroperable Automated Glycemic Controller2Product Code
- QJSInteroperable Automated Glycemic Controller, Insulin Suspend2Product Code
- QLGIntegrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems2Product Code
- QMABlood Collection Device For Cell-Free Nucleic Acid2Product Code
- QQBPrognostic Test For Assessment Of Liver Related Disease Progression2Product Code
- OJQCardiac Allograft Gene Expression Profiling Test System2Product Code
- QRXContinuous Glucose Monitor Informed Insulin Dose Calculator2Product Code
- QZGMenstrual Blood Collection Device2Product Code
- SAFIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter2Product Code
- SBHIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter2Product Code
- SFOElectrode Measurement, Drain Effluent Ph2Product Code
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
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- OphthalmicReview Panel
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- RadiologyReview Panel
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- UnknownReview Panel
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844
- Page Type
- Cleared 510(K)
- 510(k) Number
- K981883
- 510(k) Type
- Traditional
- Applicant
- BOEHRINGER MANNHEIM CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/7/1998
- Days to Decision
- 39 days
- Submission Type
- Summary