Diazo Colorimetry, Bilirubin

FDA product code CIG · 234 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1110
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-10-29 – 2026-02-27

CIG 2026-02-27

Atellica CH Diazo Total Bilirubin (D_TBil)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K251998

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CIG 2023-06-12

Atellica® CH Diazo Direct Bilirubin (D_DBil)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K223078

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CIG 2023-03-20

Atellica® CH Diazo Total Bilirubin (D_TBil)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K222104

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CIG 2022-12-29

Total Bilirubin2

Applicant Abbott Ireland Diagnostics Division

K number K223324

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CIG 2019-04-26

VITROS XT Chemistry Products TBIL-ALKP Slides

Applicant Ortho-Clinical Diagnostics, Inc.

K number K190807

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CIG 2017-07-11

ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1

Applicant Elitechgroup

K number K171401

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CIG 2013-07-17

COBAS C BILIRUBIN TOTAL GEN.3

Applicant Roche Diagnostics

K number K131544

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CIG 2013-06-07

S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN

Applicant Hitachi Chemical Diagnostics, Inc.

K number K131217

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CIG 2013-03-01

EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT

Applicant Medica Corp.

K number K123802

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CIG 2013-02-28

COBAS INTEGRA BILIRUBIN DIRECT GEN.2

Applicant Roche Diagnostics

K number K123965

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CIG 2013-02-01

ARCHITECT TOTAL BILIRUBIN

Applicant Abbott Laboratories

K number K121985

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CIG 2011-10-07

ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II

Applicant Elitechgroup

K number K110780

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CIG 2011-09-01

POLY-CHEM 90 TOTAL BILIRUBIN

Applicant Polymedco, Inc.

K number K111143

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CIG 2010-06-18

GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO

Applicant Instrumentation Laboratory CO

K number K093623

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CIG 2009-09-04

EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200

Applicant Medica Corp.

K number K091991

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CIG 2009-01-16

COBAS INTEGRA 400/800 BILIRUBIN TOTAL

Applicant Roche Diagnostics

K number K081193

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CIG 2008-12-16

TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30

Applicant Genzyme Diagnostics P.E.I., Inc.

K number K082210

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CIG 2008-12-10

EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT

Applicant Medica Corp.

K number K080810

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CIG 2008-09-05

OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181

Applicant Olympus Life Science Research Europa GmbH (Europa)

K number K080435

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CIG 2007-01-17

COBAS INTEGRA C 111

Applicant Rochdiag

K number K063744

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CIG 2006-12-22

COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226

Applicant Roche Diagnostics Corp.

K number K063543

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CIG 2006-11-01

STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+

Applicant Nova Biomedical Corp.

K number K061830

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CIG 2006-08-29

DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125

Applicant Dade Behring, Inc.

K number K061839

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CIG 2006-08-25

DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212

Applicant Dade Behring, Inc.

K number K061719

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CIG 2006-08-16

ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P

Applicant Horiba Abx

K number K060325

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CIG 2006-05-03

TOTAL BILIRUBIN

Applicant Abbott Laboratories

K number K060574

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CIG 2006-04-06

DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR

Applicant Dade Behring, Inc.

K number K060628

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CIG 2005-08-11

MODIFICATION TO ABL800 FLEX

Applicant Radiometer Medical Aps

K number K050869

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CIG 2005-06-17

SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS

Applicant Arkray, Inc.

K number K051432

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CIG 2004-06-02

TOTAL BILIRUBIN REAGENT SET

Applicant Pointe Scientific, Inc.,

K number K040391

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CIG 2004-03-18

VITALAB DIRECT BILIRUBIN REAGENT

Applicant Clinical Data, Inc.

K number K040631

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CIG 2003-09-29

ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR

Applicant Elan Diagnostics

K number K030003

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CIG 2003-09-26

ATAC TOTAL BILIRUBIN REAGENT

Applicant Elan Diagnostics

K number K030014

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CIG 2003-02-12

WIENER LAB. BILIRUBINA DIRECT AA

Applicant Wiener Laboratories Saic

K number K024116

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CIG 2002-12-11

BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30

Applicant Diagnostic Chemicals , Ltd.

K number K023330

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CIG 2002-11-01

WIENER LAB. BILIRRUBINA TOTAL AA

Applicant Wiener Laboratories Saic

K number K022962

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CIG 2002-09-13

TOTAL BILIRUBIN

Applicant Abbott Laboratories

K number K022339

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CIG 2002-09-06

DIRECT BILIRUBIN

Applicant Abbott Laboratories

K number K022180

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CIG 2001-08-27

DIRECT BILIRUBIN REAGENT

Applicant Intersect Systems, Inc.

K number K011972

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CIG 2001-02-20

TOTAL BILIRUBIN REAGENT

Applicant Intersect Systems, Inc.

K number K003892

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CIG 2001-02-12

TOTAL BILIRUBIN

Applicant Jas Diagnostics, Inc.

K number K003829

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CIG 2001-01-29

DIRECT BILIRUBIN

Applicant Jas Diagnostics, Inc.

K number K003693

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CIG 2000-04-10

BAYER ADVIA IMS SYSTEM

Applicant Bayer Corp.

K number K993867

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CIG 1999-12-27

CARESIDE DIRECT BILIRUBIN

Applicant Careside, Inc.

K number K993771

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CIG 1999-08-02

BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04

Applicant A.P. Total Care, Inc.

K number K991866

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CIG 1999-05-28

MODIFICATION TO ALCYON DIRECT BILIRUBIN

Applicant Abbott Laboratories

K number K991175

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CIG 1998-11-04

SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT

Applicant Synermed Intl., Inc.

K number K983304

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CIG 1998-09-16

TBIL

Applicant Abbott Laboratories

K number K983133

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CIG 1998-09-14

UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL

Applicant Arrows Co., Ltd.

K number K972382

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CIG 1998-07-22

DBIL

Applicant Abbott Laboratories

K number K981943

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CIG 1998-07-07

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844

Applicant Boehringer Mannheim Corp.

K number K981883

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CIG 1998-06-23

CARESIDE TOTAL BILIRUBIN

Applicant Careside, Inc.

K number K981588

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CIG 1998-06-15

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT

Applicant Roche Diagnostics/Boehringer Mannheim GmbH

K number K981632

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CIG 1998-06-03

BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30

Applicant Diagnostic Chemicals , Ltd.

K number K981609

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CIG 1998-05-01

TBIL

Applicant Abbott Laboratories

K number K981336

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CIG 1998-05-01

N-ASSAY L D-BIL

Applicant Crestat Diagnostics, Inc.

K number K981276

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CIG 1998-04-27

N-ASSAY L T-BIL

Applicant Crestat Diagnostics, Inc.

K number K981289

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CIG 1998-04-24

DIRECT BILIRUBIN (DBIL)

Applicant Abbott Laboratories

K number K981222

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CIG 1998-02-12

BILIRUBIN-SL (TOTAL) ASSAY

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K974874

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CIG 1997-09-25

SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT

Applicant Synermed, Inc.

K number K973109

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CIG 1997-08-07

SYNERMED TOTAL BILIRUBIN REAGENT KIT

Applicant Synermed, Inc.

K number K972716

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CIG 1997-06-24

TOTAL BILIRUBIN REAGENT

Applicant Carolina Liquid Chemistries Corp.

K number K972073

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CIG 1997-05-07

WAKO DIRECT BILIRUBIN V

Applicant Wako Chemicals USA, Inc.

K number K970986

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CIG 1996-12-18

SYNERMED DIRECT BILIRUBIN REAGENT KIT

Applicant Synermed, Inc.

K number K963939

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CIG 1996-08-27

DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05

Applicant Diagnostic Chemicals , Ltd.

K number K955880

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CIG 1996-03-13

TOTAL BILIRUBIN REAGENT

Applicant Derma Media Lab., Inc.

K number K955940

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CIG 1995-12-20

TOTAL BILIRUBIN PROCEDURE

Applicant Data Medical Associates, Inc.

K number K955300

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CIG 1994-12-02

BILIRUBIN(TOTAL) QVET

Applicant Prisma Systems

K number K942999

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CIG 1994-11-22

BILIRUBIN (DIRECT) QVET

Applicant Prisma Systems

K number K942949

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CIG 1994-04-26

BECKMAN DIRECT BILIRUBIN REAGENT

Applicant Beckman-Diagnostic Systems Group

K number K934068

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CIG 1994-04-20

SYNERMED TOTAL BILIRUBIN REAGENT KIT

Applicant Synermed, Inc.

K number K940570

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CIG 1993-10-28

SYNERMED DIRECT BILIRUBIN REAGENT KIT

Applicant Synermed, Inc.

K number K933026

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CIG 1993-09-21

SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406

Applicant Em Diagnostic Systems, Inc.

K number K932159

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CIG 1993-07-27

TOTAL BILIRUBIN

Applicant Em Diagnostic Systems, Inc.

K number K931888

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CIG 1993-06-29

DIRECT BILIRUBIN

Applicant Horizon Diagnostics, Inc.

K number K930679

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CIG 1992-12-03

OLYMPUS TOTAL BILIRUBIN REAGENT

Applicant Olympus Corp.

K number K924964

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CIG 1992-11-30

OLYMPUS DIRECT BILIRUBIN REAGENT

Applicant Olympus Corp.

K number K924963

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CIG 1992-10-02

OLYMPUS TOTAL BILIRUBIN REAGENT

Applicant Olympus Corp.

K number K923609

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CIG 1992-09-09

TOTAL BILIRUBIN CATALOG NO. 65407

Applicant Em Diagnostic Systems, Inc.

K number K923083

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CIG 1992-09-09

SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000

Applicant Em Diagnostic Systems, Inc.

K number K922856

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CIG 1992-08-18

OLYMPUS DIRECT BILIRUBIN REAGENT

Applicant Olympus Corp.

K number K923608

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CIG 1992-07-23

IL TEST BILIRUBIN TOTAL/DIRECT

Applicant Instrumentation Laboratory CO

K number K920653

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CIG 1992-07-21

KODAK EKTACHEM DT SLIDES (NBIL)

Applicant Eastman Kodak Company

K number K921844

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CIG 1991-12-04