Product code CIG— Clinical Chemistry
DIRECT BILIRUBIN REAGENT
- Classification name
- Diazo Colorimetry, Bilirubin
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Total cleared
- 235
- First cleared
- Most recent
Market context for product code CIG
FDA has cleared devices under product code CIG between 1976 and 2026, filed by 106 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2023
- 2022
- 2019
- 2017
- 2015
- 2013
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
Top applicants under product code CIG
Recent clearances under product code CIG
1–100 of 235- K251998 — Atellica CH Diazo Total Bilirubin (D_TBil)
- K223078 — Atellica® CH Diazo Direct Bilirubin (D_DBil)
- K222104 — Atellica® CH Diazo Total Bilirubin (D_TBil)
- K223324 — Total Bilirubin2
- K190807 — VITROS XT Chemistry Products TBIL-ALKP Slides
- K171401 — ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
- K150510 — Total Bilirubin
- K131544 — COBAS C BILIRUBIN TOTAL GEN.3
- K131217 — S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN
- K123802 — EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT
- K123965 — COBAS INTEGRA BILIRUBIN DIRECT GEN.2
- K121985 — ARCHITECT TOTAL BILIRUBIN
- K110780 — ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II
- K111143 — POLY-CHEM 90 TOTAL BILIRUBIN
- K093623 — GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO
- K091991 — EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200
- K081193 — COBAS INTEGRA 400/800 BILIRUBIN TOTAL
- K082210 — TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
- K080810 — EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT
- K080435 — OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
- K063744 — COBAS INTEGRA C 111
- K063543 — COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226
- K061830 — STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+
- K061839 — DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125
- K061719 — DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212
- K060325 — ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P
- K060574 — TOTAL BILIRUBIN
- K060628 — DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR
- K050869 — MODIFICATION TO ABL800 FLEX
- K051432 — SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS
- K040391 — TOTAL BILIRUBIN REAGENT SET
- K040631 — VITALAB DIRECT BILIRUBIN REAGENT
- K030003 — ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR
- K030014 — ATAC TOTAL BILIRUBIN REAGENT
- K024116 — WIENER LAB. BILIRUBINA DIRECT AA
- K023330 — BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30
- K022962 — WIENER LAB. BILIRRUBINA TOTAL AA
- K022339 — TOTAL BILIRUBIN
- K022180 — DIRECT BILIRUBIN
- K011972 — DIRECT BILIRUBIN REAGENT
- K003892 — TOTAL BILIRUBIN REAGENT
- K003829 — TOTAL BILIRUBIN
- K003693 — DIRECT BILIRUBIN
- K993867 — BAYER ADVIA IMS SYSTEM
- K993771 — CARESIDE DIRECT BILIRUBIN
- K991866 — BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04
- K991175 — MODIFICATION TO ALCYON DIRECT BILIRUBIN
- K983304 — SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT
- K983133 — TBIL
- K972382 — UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL
- K981943 — DBIL
- K981883 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844
- K981588 — CARESIDE TOTAL BILIRUBIN
- K981632 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT
- K981609 — BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30
- K981276 — N-ASSAY L D-BIL
- K981336 — TBIL
- K981289 — N-ASSAY L T-BIL
- K981222 — DIRECT BILIRUBIN (DBIL)
- K974874 — BILIRUBIN-SL (TOTAL) ASSAY
- K973109 — SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT
- K972716 — SYNERMED TOTAL BILIRUBIN REAGENT KIT
- K972073 — TOTAL BILIRUBIN REAGENT
- K970986 — WAKO DIRECT BILIRUBIN V
- K963939 — SYNERMED DIRECT BILIRUBIN REAGENT KIT
- K955880 — DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05
- K955940 — TOTAL BILIRUBIN REAGENT
- K955300 — TOTAL BILIRUBIN PROCEDURE
- K942999 — BILIRUBIN(TOTAL) QVET
- K942949 — BILIRUBIN (DIRECT) QVET
- K934068 — BECKMAN DIRECT BILIRUBIN REAGENT
- K940570 — SYNERMED TOTAL BILIRUBIN REAGENT KIT
- K933026 — SYNERMED DIRECT BILIRUBIN REAGENT KIT
- K932159 — SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406
- K931888 — TOTAL BILIRUBIN
- K930679 — DIRECT BILIRUBIN
- K924964 — OLYMPUS TOTAL BILIRUBIN REAGENT
- K924963 — OLYMPUS DIRECT BILIRUBIN REAGENT
- K923609 — OLYMPUS TOTAL BILIRUBIN REAGENT
- K922856 — SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000
- K923083 — TOTAL BILIRUBIN CATALOG NO. 65407
- K923608 — OLYMPUS DIRECT BILIRUBIN REAGENT
- K920653 — IL TEST BILIRUBIN TOTAL/DIRECT
- K921844 — KODAK EKTACHEM DT SLIDES (NBIL)
- K914873 — DIAZO COLORIMETRY, BILIRUBIN
- K913466 — ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20
- K913307 — ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21
- K912733 — AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT
- K911866 — TRACE TOTAL/DIRECT BILIRUBIN REAGENT
- K910635 — TOTAL BILIRUBIN REAGENT SET
- K910591 — ROCHE REAGENT FOR TOTAL BILIRUBIN
- K910593 — ROCHE REAGENT FOR DIRECT BILIRUBIN
- K904468 — DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176
- K905622 — COULTER DIRECT BILLRUBIN REAGENT
- K904381 — DIAZO COLORIMENTRY DIRECT BILIRUBIN
- K903728 — SYNERMED DIRECT BILIRUBIN REAGENT KIT
- K902801 — BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT
- K902328 — SYNERMED TOTAL BILIRUBIN REAGENT KIT
- K902199 — COULTER DIRECT BILIRUBIN
- K902123 — SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406
Data sourced from openFDA. This site is unofficial and independent of the FDA.