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| Atellica® CH Diazo Direct Bilirubin (D_DBil) (K223078) | Siemens Healthcare Diagnostics, Inc. | 2023-06-12 |
| Atellica® CH Diazo Total Bilirubin (D_TBil) (K222104) | Siemens Healthcare Diagnostics, Inc. | 2023-03-20 |
| Total Bilirubin2 (K223324) | Abbott Ireland Diagnostics Division | 2022-12-29 |
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| ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 (K171401) | Elitechgroup | 2017-07-11 |
| Total Bilirubin (K150510) | Abbott Laboratories | 2015-04-02 |
| COBAS C BILIRUBIN TOTAL GEN.3 (K131544) | Roche Diagnostics | 2013-07-17 |
| S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN (K131217) | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 |
| EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT (K123802) | Medica Corp. | 2013-03-01 |
| COBAS INTEGRA BILIRUBIN DIRECT GEN.2 (K123965) | Roche Diagnostics | 2013-02-28 |
| ARCHITECT TOTAL BILIRUBIN (K121985) | Abbott Laboratories | 2013-02-01 |
| ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II (K110780) | Elitechgroup | 2011-10-07 |
| POLY-CHEM 90 TOTAL BILIRUBIN (K111143) | Polymedco, Inc. | 2011-09-01 |
| GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO (K093623) | Instrumentation Laboratory CO | 2010-06-18 |
| EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 (K091991) | Medica Corp. | 2009-09-04 |
| COBAS INTEGRA 400/800 BILIRUBIN TOTAL (K081193) | Roche Diagnostics | 2009-01-16 |
| TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 (K082210) | Genzyme Diagnostics P.E.I., Inc. | 2008-12-16 |
| EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT (K080810) | Medica Corp. | 2008-12-10 |
| OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 (K080435) | Olympus Life Science Research Europa GmbH (Europa) | 2008-09-05 |
| COBAS INTEGRA C 111 (K063744) | Rochdiag | 2007-01-17 |
| COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226 (K063543) | Roche Diagnostics Corp. | 2006-12-22 |
| STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ (K061830) | Nova Biomedical Corp. | 2006-11-01 |
| DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125 (K061839) | Dade Behring, Inc. | 2006-08-29 |
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| ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P (K060325) | Horiba Abx | 2006-08-16 |
| TOTAL BILIRUBIN (K060574) | Abbott Laboratories | 2006-05-03 |
| DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR (K060628) | Dade Behring, Inc. | 2006-04-06 |
| MODIFICATION TO ABL800 FLEX (K050869) | Radiometer Medical Aps | 2005-08-11 |
| SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS (K051432) | Arkray, Inc. | 2005-06-17 |
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| VITALAB DIRECT BILIRUBIN REAGENT (K040631) | Clinical Data, Inc. | 2004-03-18 |
| ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR (K030003) | Elan Diagnostics | 2003-09-29 |
| ATAC TOTAL BILIRUBIN REAGENT (K030014) | Elan Diagnostics | 2003-09-26 |
| WIENER LAB. BILIRUBINA DIRECT AA (K024116) | Wiener Laboratories Saic | 2003-02-12 |
| BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30 (K023330) | Diagnostic Chemicals , Ltd. | 2002-12-11 |
| WIENER LAB. BILIRRUBINA TOTAL AA (K022962) | Wiener Laboratories Saic | 2002-11-01 |
| TOTAL BILIRUBIN (K022339) | Abbott Laboratories | 2002-09-13 |
| DIRECT BILIRUBIN (K022180) | Abbott Laboratories | 2002-09-06 |
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| TOTAL BILIRUBIN REAGENT (K003892) | Intersect Systems, Inc. | 2001-02-20 |
| TOTAL BILIRUBIN (K003829) | Jas Diagnostics, Inc. | 2001-02-12 |
| DIRECT BILIRUBIN (K003693) | Jas Diagnostics, Inc. | 2001-01-29 |
| BAYER ADVIA IMS SYSTEM (K993867) | Bayer Corp. | 2000-04-10 |
| CARESIDE DIRECT BILIRUBIN (K993771) | Careside, Inc. | 1999-12-27 |
| BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 (K991866) | A.P. Total Care, Inc. | 1999-08-02 |
| MODIFICATION TO ALCYON DIRECT BILIRUBIN (K991175) | Abbott Laboratories | 1999-05-28 |
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| TBIL (K983133) | Abbott Laboratories | 1998-09-16 |
| UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL (K972382) | Arrows Co., Ltd. | 1998-09-14 |
| DBIL (K981943) | Abbott Laboratories | 1998-07-22 |
| ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844 (K981883) | Boehringer Mannheim Corp. | 1998-07-07 |
| CARESIDE TOTAL BILIRUBIN (K981588) | Careside, Inc. | 1998-06-23 |
| ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT (K981632) | Roche Diagnostics/Boehringer Mannheim GmbH | 1998-06-15 |
| BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 (K981609) | Diagnostic Chemicals , Ltd. | 1998-06-03 |
| TBIL (K981336) | Abbott Laboratories | 1998-05-01 |
| N-ASSAY L D-BIL (K981276) | Crestat Diagnostics, Inc. | 1998-05-01 |
| N-ASSAY L T-BIL (K981289) | Crestat Diagnostics, Inc. | 1998-04-27 |
| DIRECT BILIRUBIN (DBIL) (K981222) | Abbott Laboratories | 1998-04-24 |
| BILIRUBIN-SL (TOTAL) ASSAY (K974874) | Diagnostic Chemicals, Ltd. (Usa) | 1998-02-12 |
| SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT (K973109) | Synermed, Inc. | 1997-09-25 |
| SYNERMED TOTAL BILIRUBIN REAGENT KIT (K972716) | Synermed, Inc. | 1997-08-07 |
| TOTAL BILIRUBIN REAGENT (K972073) | Carolina Liquid Chemistries Corp. | 1997-06-24 |
| WAKO DIRECT BILIRUBIN V (K970986) | Wako Chemicals USA, Inc. | 1997-05-07 |
| SYNERMED DIRECT BILIRUBIN REAGENT KIT (K963939) | Synermed, Inc. | 1996-12-18 |
| DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05 (K955880) | Diagnostic Chemicals , Ltd. | 1996-08-27 |
| TOTAL BILIRUBIN REAGENT (K955940) | Derma Media Lab., Inc. | 1996-03-13 |
| TOTAL BILIRUBIN PROCEDURE (K955300) | Data Medical Associates, Inc. | 1995-12-20 |
| BILIRUBIN(TOTAL) QVET (K942999) | Prisma Systems | 1994-12-02 |
| BILIRUBIN (DIRECT) QVET (K942949) | Prisma Systems | 1994-11-22 |
| BECKMAN DIRECT BILIRUBIN REAGENT (K934068) | Beckman-Diagnostic Systems Group | 1994-04-26 |
| SYNERMED TOTAL BILIRUBIN REAGENT KIT (K940570) | Synermed, Inc. | 1994-04-20 |
| SYNERMED DIRECT BILIRUBIN REAGENT KIT (K933026) | Synermed, Inc. | 1993-10-28 |
| SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406 (K932159) | Em Diagnostic Systems, Inc. | 1993-09-21 |
| TOTAL BILIRUBIN (K931888) | Em Diagnostic Systems, Inc. | 1993-07-27 |
| DIRECT BILIRUBIN (K930679) | Horizon Diagnostics, Inc. | 1993-06-29 |
| OLYMPUS TOTAL BILIRUBIN REAGENT (K924964) | Olympus Corp. | 1992-12-03 |
| OLYMPUS DIRECT BILIRUBIN REAGENT (K924963) | Olympus Corp. | 1992-11-30 |
| OLYMPUS TOTAL BILIRUBIN REAGENT (K923609) | Olympus Corp. | 1992-10-02 |
| TOTAL BILIRUBIN CATALOG NO. 65407 (K923083) | Em Diagnostic Systems, Inc. | 1992-09-09 |
| SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000 (K922856) | Em Diagnostic Systems, Inc. | 1992-09-09 |
| OLYMPUS DIRECT BILIRUBIN REAGENT (K923608) | Olympus Corp. | 1992-08-18 |
| IL TEST BILIRUBIN TOTAL/DIRECT (K920653) | Instrumentation Laboratory CO | 1992-07-23 |
| KODAK EKTACHEM DT SLIDES (NBIL) (K921844) | Eastman Kodak Company | 1992-07-21 |
| DIAZO COLORIMETRY, BILIRUBIN (K914873) | Pointe Scientific, Inc., | 1991-12-04 |
| ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20 (K913466) | Em Diagnostic Systems, Inc. | 1991-10-25 |
| ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21 (K913307) | Em Diagnostic Systems, Inc. | 1991-10-11 |
| AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT (K912733) | Amersham Corp. | 1991-07-22 |
| TRACE TOTAL/DIRECT BILIRUBIN REAGENT (K911866) | Trace Scientific , Ltd. | 1991-07-17 |
| TOTAL BILIRUBIN REAGENT SET (K910635) | Biochemical Trade, Inc. | 1991-05-15 |
| ROCHE REAGENT FOR DIRECT BILIRUBIN (K910593) | Roche Diagnostic Systems, Inc. | 1991-04-24 |
| ROCHE REAGENT FOR TOTAL BILIRUBIN (K910591) | Roche Diagnostic Systems, Inc. | 1991-04-24 |
| DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 (K904468) | Amresco, Inc. | 1991-01-17 |
| COULTER DIRECT BILLRUBIN REAGENT (K905622) | Coulter Electronics, Inc. | 1990-12-26 |
| DIAZO COLORIMENTRY DIRECT BILIRUBIN (K904381) | Amresco, Inc. | 1990-10-12 |
| SYNERMED DIRECT BILIRUBIN REAGENT KIT (K903728) | Synermed, Inc. | 1990-09-21 |
| BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT (K902801) | Beckman Instruments, Inc. | 1990-07-17 |
| SYNERMED TOTAL BILIRUBIN REAGENT KIT (K902328) | Synermed, Inc. | 1990-06-28 |
| COULTER DIRECT BILIRUBIN (K902199) | Coulter Corp. | 1990-06-12 |
| SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406 (K902123) | Em Diagnostic Systems, Inc. | 1990-06-06 |