Product Code: CIG FDA class 2 21 CFR 862.1110

Diazo Colorimetry, Bilirubin

Clinical Chemistry

The Diazo Colorimetry, Bilirubin test system (product code CIG) is an in-vitro diagnostic device used in clinical chemistry to measure bilirubin concentrations in serum or plasma using the diazo reaction (Jendrassik-Grof or similar method), supporting the evaluation of liver function and hemolytic conditions. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1110 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

View on FDA

510(k)s

234

FEI Numbers

Registration Numbers

Unique Applicants

107

Years Active

Basic Information

Product Code: CIG
Device Class: FDA class 2
Regulation Number: 862.1110
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 234 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K223078	Atellica® CH Diazo Direct Bilirubin (D_DBil)	Jun 12, 2023	Substantially Equivalent	Siemens Healthcare Diagnostics Inc.
K222104	Atellica® CH Diazo Total Bilirubin (D_TBil)	Mar 20, 2023	Substantially Equivalent	Siemens Healthcare Diagnostics Inc.
K223324	Total Bilirubin2	Dec 29, 2022	Substantially Equivalent	Abbott Ireland Diagnostics Division
K190807	VITROS XT Chemistry Products TBIL-ALKP Slides	Apr 26, 2019	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K171401	ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1	Jul 11, 2017	Substantially Equivalent	ELITechGroup
K150510	Total Bilirubin	Apr 02, 2015	Substantially Equivalent	ABBOTT LABORATORIES
K131544	COBAS C BILIRUBIN TOTAL GEN.3	Jul 17, 2013	Substantially Equivalent	Roche Diagnostics
K131217	S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN	Jun 07, 2013	Substantially Equivalent	HITACHI CHEMICAL DIAGNOSTICS, INC.
K123802	EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT	Mar 01, 2013	Substantially Equivalent	MEDICA CORP.
K123965	COBAS INTEGRA BILIRUBIN DIRECT GEN.2	Feb 28, 2013	Substantially Equivalent	Roche Diagnostics
K121985	ARCHITECT TOTAL BILIRUBIN	Feb 01, 2013	Substantially Equivalent	ABBOTT LABORATORIES
K110780	ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II	Oct 07, 2011	Substantially Equivalent	ELITECH GROUP
K111143	POLY-CHEM 90 TOTAL BILIRUBIN	Sep 01, 2011	Substantially Equivalent	POLYMEDCO, INC.
K093623	GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO	Jun 18, 2010	Substantially Equivalent	INSTRUMENTATION LABORATORY CO.
K091991	EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200	Sep 04, 2009	Substantially Equivalent	MEDICA CORP.
K081193	COBAS INTEGRA 400/800 BILIRUBIN TOTAL	Jan 16, 2009	Substantially Equivalent	Roche Diagnostics
K082210	TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30	Dec 16, 2008	Substantially Equivalent	GENZYME DIAGNOSTICS P.E.I. INC.
K080810	EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT	Dec 10, 2008	Substantially Equivalent	MEDICA CORP.
K080435	OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181	Sep 05, 2008	Substantially Equivalent	OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
K063744	COBAS INTEGRA C 111	Jan 17, 2007	Substantially Equivalent	ROCHDIAG
K063543	COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226	Dec 22, 2006	Substantially Equivalent	ROCHE DIAGNOSTICS CORP.
K061830	STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+	Nov 01, 2006	Substantially Equivalent	NOVA BIOMEDICAL CORP.
K061839	DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125	Aug 29, 2006	Substantially Equivalent	DADE BEHRING, INC.
K061719	DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212	Aug 25, 2006	Substantially Equivalent	DADE BEHRING, INC.
K060325	ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P	Aug 16, 2006	Substantially Equivalent	HORIBA ABX
K060574	TOTAL BILIRUBIN	May 03, 2006	Substantially Equivalent	ABBOTT LABORATORIES
K060628	DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR	Apr 06, 2006	Substantially Equivalent	DADE BEHRING, INC.
K050869	MODIFICATION TO ABL800 FLEX	Aug 11, 2005	Substantially Equivalent	RADIOMETER MEDICAL APS
K051432	SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS	Jun 17, 2005	Substantially Equivalent	ARKRAY, INC.
K040391	TOTAL BILIRUBIN REAGENT SET	Jun 02, 2004	Substantially Equivalent	POINTE SCIENTIFIC, INC.
K040631	VITALAB DIRECT BILIRUBIN REAGENT	Mar 18, 2004	Substantially Equivalent	CLINICAL DATA, INC.
K030003	ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR	Sep 29, 2003	Substantially Equivalent	ELAN DIAGNOSTICS
K030014	ATAC TOTAL BILIRUBIN REAGENT	Sep 26, 2003	Substantially Equivalent	ELAN DIAGNOSTICS
K024116	WIENER LAB. BILIRUBINA DIRECT AA	Feb 12, 2003	Substantially Equivalent	WIENER LABORATORIES S.A.I.C.
K023330	BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30	Dec 11, 2002	Substantially Equivalent	DIAGNOSTIC CHEMICALS LTD.
K022962	WIENER LAB. BILIRRUBINA TOTAL AA	Nov 01, 2002	Substantially Equivalent	WIENER LABORATORIES S.A.I.C.
K022339	TOTAL BILIRUBIN	Sep 13, 2002	Substantially Equivalent	ABBOTT LABORATORIES
K022180	DIRECT BILIRUBIN	Sep 06, 2002	Substantially Equivalent	ABBOTT LABORATORIES
K011972	DIRECT BILIRUBIN REAGENT	Aug 27, 2001	Substantially Equivalent	INTERSECT SYSTEMS, INC.
K003892	TOTAL BILIRUBIN REAGENT	Feb 20, 2001	Substantially Equivalent	INTERSECT SYSTEMS, INC.
K003829	TOTAL BILIRUBIN	Feb 12, 2001	Substantially Equivalent	JAS Diagnostics, Inc.
K003693	DIRECT BILIRUBIN	Jan 29, 2001	Substantially Equivalent	JAS Diagnostics, Inc.
K993867	BAYER ADVIA IMS SYSTEM	Apr 10, 2000	Substantially Equivalent	BAYER CORP.
K993771	CARESIDE DIRECT BILIRUBIN	Dec 27, 1999	Substantially Equivalent	CARESIDE, INC.
K991866	BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04	Aug 02, 1999	Substantially Equivalent	A.P. TOTAL CARE, INC.
K991175	MODIFICATION TO ALCYON DIRECT BILIRUBIN	May 28, 1999	Substantially Equivalent	ABBOTT LABORATORIES
K983304	SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT	Nov 04, 1998	Substantially Equivalent	SYNERMED INTL., INC.
K983133	TBIL	Sep 16, 1998	Substantially Equivalent	ABBOTT LABORATORIES
K972382	UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL	Sep 14, 1998	Substantially Equivalent	ARROWS CO., LTD.
K981943	DBIL	Jul 22, 1998	Substantially Equivalent	ABBOTT LABORATORIES
K981883	ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844	Jul 07, 1998	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K981588	CARESIDE TOTAL BILIRUBIN	Jun 23, 1998	Substantially Equivalent	CARESIDE, INC.
K981632	ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT	Jun 15, 1998	Substantially Equivalent	ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH
K981609	BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30	Jun 03, 1998	Substantially Equivalent	DIAGNOSTIC CHEMICALS LTD.
K981336	TBIL	May 01, 1998	Substantially Equivalent	ABBOTT LABORATORIES
K981276	N-ASSAY L D-BIL	May 01, 1998	Substantially Equivalent	CRESTAT DIAGNOSTICS, INC.
K981289	N-ASSAY L T-BIL	Apr 27, 1998	Substantially Equivalent	CRESTAT DIAGNOSTICS, INC.
K981222	DIRECT BILIRUBIN (DBIL)	Apr 24, 1998	Substantially Equivalent	ABBOTT LABORATORIES
K974874	BILIRUBIN-SL (TOTAL) ASSAY	Feb 12, 1998	Substantially Equivalent	DIAGNOSTIC CHEMICALS, LTD. (USA)
K973109	SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT	Sep 25, 1997	Substantially Equivalent	SYNERMED, INC.
K972716	SYNERMED TOTAL BILIRUBIN REAGENT KIT	Aug 07, 1997	Substantially Equivalent	SYNERMED, INC.
K972073	TOTAL BILIRUBIN REAGENT	Jun 24, 1997	Substantially Equivalent	CAROLINA LIQUID CHEMISTRIES CORP.
K970986	WAKO DIRECT BILIRUBIN V	May 07, 1997	Substantially Equivalent	WAKO CHEMICALS, USA, INC.
K963939	SYNERMED DIRECT BILIRUBIN REAGENT KIT	Dec 18, 1996	Substantially Equivalent	SYNERMED, INC.
K955880	DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05	Aug 27, 1996	Substantially Equivalent	DIAGNOSTIC CHEMICALS LTD.
K955940	TOTAL BILIRUBIN REAGENT	Mar 13, 1996	Substantially Equivalent	DERMA MEDIA LAB., INC.
K955300	TOTAL BILIRUBIN PROCEDURE	Dec 20, 1995	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K942999	BILIRUBIN(TOTAL) QVET	Dec 02, 1994	Substantially Equivalent	PRISMA SYSTEMS
K942949	BILIRUBIN (DIRECT) QVET	Nov 22, 1994	Substantially Equivalent	PRISMA SYSTEMS
K934068	BECKMAN DIRECT BILIRUBIN REAGENT	Apr 26, 1994	Substantially Equivalent	BECKMAN-DIAGNOSTIC SYSTEMS GROUP
K940570	SYNERMED TOTAL BILIRUBIN REAGENT KIT	Apr 20, 1994	Substantially Equivalent	SYNERMED, INC.
K933026	SYNERMED DIRECT BILIRUBIN REAGENT KIT	Oct 28, 1993	Substantially Equivalent	SYNERMED, INC.
K932159	SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406	Sep 21, 1993	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K931888	TOTAL BILIRUBIN	Jul 27, 1993	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K930679	DIRECT BILIRUBIN	Jun 29, 1993	Substantially Equivalent	HORIZON DIAGNOSTICS, INC.
K924964	OLYMPUS TOTAL BILIRUBIN REAGENT	Dec 03, 1992	Substantially Equivalent	OLYMPUS CORP.
K924963	OLYMPUS DIRECT BILIRUBIN REAGENT	Nov 30, 1992	Substantially Equivalent	OLYMPUS CORP.
K923609	OLYMPUS TOTAL BILIRUBIN REAGENT	Oct 02, 1992	Substantially Equivalent	OLYMPUS CORP.
K923083	TOTAL BILIRUBIN CATALOG NO. 65407	Sep 09, 1992	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K922856	SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000	Sep 09, 1992	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K923608	OLYMPUS DIRECT BILIRUBIN REAGENT	Aug 18, 1992	Substantially Equivalent	OLYMPUS CORP.
K920653	IL TEST BILIRUBIN TOTAL/DIRECT	Jul 23, 1992	Substantially Equivalent	INSTRUMENTATION LABORATORY CO.
K921844	KODAK EKTACHEM DT SLIDES (NBIL)	Jul 21, 1992	Substantially Equivalent	EASTMAN KODAK COMPANY
K914873	DIAZO COLORIMETRY, BILIRUBIN	Dec 04, 1991	Substantially Equivalent	POINTE SCIENTIFIC, INC.
K913466	ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20	Oct 25, 1991	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K913307	ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21	Oct 11, 1991	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K912733	AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT	Jul 22, 1991	Substantially Equivalent	AMERSHAM CORP.
K911866	TRACE TOTAL/DIRECT BILIRUBIN REAGENT	Jul 17, 1991	Substantially Equivalent	TRACE SCIENTIFIC LTD.
K910635	TOTAL BILIRUBIN REAGENT SET	May 15, 1991	Substantially Equivalent	BIOCHEMICAL TRADE, INC.
K910593	ROCHE REAGENT FOR DIRECT BILIRUBIN	Apr 24, 1991	Substantially Equivalent	ROCHE DIAGNOSTIC SYSTEMS, INC.
K910591	ROCHE REAGENT FOR TOTAL BILIRUBIN	Apr 24, 1991	Substantially Equivalent	ROCHE DIAGNOSTIC SYSTEMS, INC.
K904468	DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176	Jan 17, 1991	Substantially Equivalent	AMRESCO, INC.
K905622	COULTER DIRECT BILLRUBIN REAGENT	Dec 26, 1990	Substantially Equivalent	COULTER ELECTRONICS, INC.
K904381	DIAZO COLORIMENTRY DIRECT BILIRUBIN	Oct 12, 1990	Substantially Equivalent	AMRESCO, INC.
K903728	SYNERMED DIRECT BILIRUBIN REAGENT KIT	Sep 21, 1990	Substantially Equivalent	SYNERMED, INC.
K902801	BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT	Jul 17, 1990	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K902328	SYNERMED TOTAL BILIRUBIN REAGENT KIT	Jun 28, 1990	Substantially Equivalent	SYNERMED, INC.
K902199	COULTER DIRECT BILIRUBIN	Jun 12, 1990	Substantially Equivalent	COULTER CORP.
K902123	SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406	Jun 06, 1990	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K897174	OLYMPUS(TM) TOTAL BILIRUBIN	May 10, 1990	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K901266	COULTER TOTAL BILIRUBIN REAGENT	Apr 25, 1990	Substantially Equivalent	COULTER CORP.
K900571	AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD)	Apr 16, 1990	Substantially Equivalent	AMERICAN RESEARCH PRODUCTS CO.
K897176	SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX	Mar 19, 1990	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K897175	OLYMPUS DIRECT BILIRUBIN	Mar 15, 1990	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K900259	DIRECT BILIRUBIN REAGENT	Feb 27, 1990	Substantially Equivalent	MEDICAL ANALYSIS SYSTEMS, INC.
K896232	COBAS READY TOTAL BILIRUBIN REAGENT	Feb 27, 1990	Substantially Equivalent	ROCHE DIAGNOSTIC SYSTEMS, INC.
K895822	TOTAL BILIRUBIN L.F.	Nov 14, 1989	Substantially Equivalent	SCLAVO, INC.
K895119	SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406	Oct 17, 1989	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K895118	SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407	Oct 17, 1989	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K892801	CLINISTAT TOTAL BILIRUBIN REAGENT TEST	Aug 15, 1989	Substantially Equivalent	HERAEUS KULZER, INC.
K893730	DIRECT BILIRUBIN REAGENT	Aug 11, 1989	Substantially Equivalent	MEDICAL ANALYSIS SYSTEMS, INC.
K892668	TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS	Jul 20, 1989	Substantially Equivalent	CATACHEM, INC.
K892905	DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.	Jun 19, 1989	Substantially Equivalent	CATACHEM, INC.
K891240	DIRECT BILIRUBIN FOR CONTINUOUS FLOW	May 10, 1989	Substantially Equivalent	CATACHEM, INC.
K891025	TOTAL BILIRUBIN FOR CONTINUOUS FLOW	Apr 04, 1989	Substantially Equivalent	CATACHEM, INC.
K890070	TOTAL BILIRUBIN REAGENT, CONCENTRATED	Mar 06, 1989	Substantially Equivalent	TRACE SCIENTIFIC LTD.
K885285	DIRECT BILIRUBIN TEST CATALOG NO. SR1008	Jan 30, 1989	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K885284	TOTAL BILIRUBIN TEST CATALOG NO. SR1007	Jan 30, 1989	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K871115	UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON.	Jan 27, 1989	Substantially Equivalent	LABO SCIENCE-USA, INC.
K884224	TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS	Dec 15, 1988	Substantially Equivalent	A-KEM, INC.
K880437	VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM	Aug 03, 1988	Substantially Equivalent	ABBOTT LABORATORIES
K882459	DIAZO, COLORIMETRIC BILIRUBIN	Aug 02, 1988	Substantially Equivalent	TECH-NEAL SCIENTIFIC, INC.
K881798	TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN	Jun 07, 1988	Substantially Equivalent	TECHNICON INSTRUMENTS CORP.
K881172	BILIRUBIN (DIRECT)	Jun 07, 1988	Substantially Equivalent	TECH-CO, INC.
K881241	TOTAL BILIRUBIN REAGENT	May 27, 1988	Substantially Equivalent	TECH-NEAL SCIENTIFIC, INC.
K881166	DIRECT BILIRUBIN PROCEDURE	Apr 28, 1988	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K880743	ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT	Apr 05, 1988	Substantially Equivalent	ABBOTT LABORATORIES
K880397	DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.	Mar 15, 1988	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K880396	TOTAL BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.	Mar 15, 1988	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K880395	TOTAL BILIRUBIN PROCEDURE RUN ON A DEMAND INSTRU.	Mar 15, 1988	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K875069	BILIRUBIN (TOTAL)	Jan 11, 1988	Substantially Equivalent	TECH-CO, INC.
K874311	MULTICHEM (R) TOTAL BILIRUBIN	Nov 25, 1987	Substantially Equivalent	SIMMLER, INC.
K874261	IQ/QCA TOTAL BILIRUBIN	Nov 25, 1987	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K872818	REFLOTRON BILIRUBIN	Nov 23, 1987	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K873551	CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95	Oct 02, 1987	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K873424	EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690	Sep 14, 1987	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K872513	EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604	Aug 21, 1987	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K872512	EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95	Aug 21, 1987	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K872487	VISION(R) TOTAL BILIRUBIN	Aug 21, 1987	Substantially Equivalent	ABBOTT LABORATORIES
K870365	DIRECT BILIRUBIN REAGENT - ACID DIAZO METHOD	Aug 19, 1987	Substantially Equivalent	TRACE SCIENTIFIC LTD.
K870364	TOTAL BILIRUBIN REAGENT - DMSO METHOD	Aug 19, 1987	Substantially Equivalent	TRACE SCIENTIFIC LTD.
K872197	PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT	Aug 13, 1987	Substantially Equivalent	SIGMA DIAGNOSTICS, INC.
K870095	BILIRUBIN TESTER	Jun 03, 1987	Substantially Equivalent	WAKO CHEMICALS, USA, INC.
K871531	REAGENTS 1263,1273,1284,1425,014301,053583	May 18, 1987	Substantially Equivalent	AMERICAN RESEARCH PRODUCTS CO.
K871530	TOTAL BILIRUBIN REAGENT 1372,1425,1284,1273,053583	May 14, 1987	Substantially Equivalent	AMERICAN RESEARCH PRODUCTS CO.
K863056	BILIRUBIN TOTAL	Nov 24, 1986	Substantially Equivalent	J. D. ASSOC.
K863265	DIRECT BILIRUBIN PROCEDURE	Oct 24, 1986	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K863057	BILIRUBIN TOTAL DIRECT	Sep 26, 1986	Substantially Equivalent	J. D. ASSOC.
K863262	TOTAL BILIRUBIN PROCEDURE	Sep 17, 1986	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K863055	BILIFAST	Sep 09, 1986	Substantially Equivalent	J. D. ASSOC.
K862359	METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM	Aug 19, 1986	Substantially Equivalent	E.I. DUPONT DE NEMOURS & CO., INC.
K862299	AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS	Jul 01, 1986	Substantially Equivalent	AMRESCO, INC.
K861998	TOTAL BILIRUBIN TEST KIT	Jun 27, 1986	Substantially Equivalent	CIBA CORNING DIAGNOSTICS CORP.
K861671	DIRECT BILIRUBIN PROCEDURE	Jun 25, 1986	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K861651	TOTAL BILIRUBIN PROCEDURE	May 29, 1986	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K861413	BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET	Apr 24, 1986	Substantially Equivalent	MEDICAL ANALYSIS SYSTEMS, INC.
K861095	BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04	Apr 21, 1986	Substantially Equivalent	DIAGNOSTIC CHEMICALS, LTD. (USA)
K861094	BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02	Apr 21, 1986	Substantially Equivalent	DIAGNOSTIC CHEMICALS, LTD. (USA)
K860424	A-GENT LIQUID TOTAL BILIRUBIN	Apr 03, 1986	Substantially Equivalent	ABBOTT LABORATORIES
K860214	TOTAL BILIRUBIN REAGENT SET	Mar 17, 1986	Substantially Equivalent	STERLING DIAGNOSTICS, INC.
K855079	NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95	Mar 05, 1986	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K860257	DIRECT BILIRUBIN	Feb 21, 1986	Substantially Equivalent	POINTE SCIENTIFIC, INC.
K855195	DIRECT & TOTAL BILIRUBIN SET	Jan 14, 1986	Substantially Equivalent	TECHNOSTICS INTL.
K854180	IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN	Nov 25, 1985	Substantially Equivalent	CLINICAL DATA, INC.
K852008	T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL	May 30, 1985	Substantially Equivalent	ALPKEM CORP.
K850748	I-L TEST, DIRECT BILIRUBIN SET	Apr 03, 1985	Substantially Equivalent	ALLIED INSTRUMENTATION LABORATORY
K843908	ABBOTT TDT EIA	Apr 03, 1985	Substantially Equivalent	ABBOTT LABORATORIES
K850901	DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE	Apr 01, 1985	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K850379	DIRECT BILIRUBIN FOR DEMAND ANALYZER	Mar 01, 1985	Substantially Equivalent	ADVANCED BIOMEDICAL METHODS, INC.
K843329	SYSTEMATE D-BILI 67213	Sep 20, 1984	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K843328	SYSTEMATE T-BILI 67212	Sep 20, 1984	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K843178	TOTAL BILIRUBIN TEST	Sep 07, 1984	Substantially Equivalent	SCLAVO, INC.
K843032	BILIRUBIN ASSAY KIT - TOTAL	Sep 04, 1984	Substantially Equivalent	DIAGNOSTIC CHEMICALS, LTD. (USA)
K843027	BILIRUBIN ASSAY KIT DIRECT	Sep 04, 1984	Substantially Equivalent	DIAGNOSTIC CHEMICALS, LTD. (USA)
K842809	TECHNICON RA-1000 SYS, DIRECT BILIRUBIN	Aug 17, 1984	Substantially Equivalent	TECHNICON INSTRUMENTS CORP.
K842385	ACA CONJUGATED BILIRUBIN ANALYTICAL	Aug 17, 1984	Substantially Equivalent	E.I. DUPONT DE NEMOURS & CO., INC.
K841892	RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT	Jun 07, 1984	Substantially Equivalent	REAGENTS APPLICATIONS, INC.
K840757	ELVI 444 BILITRON	May 30, 1984	Substantially Equivalent	LOGOS SCIENTIFIC, INC.
K841572	DIRECT BILIRUBIN REAGENT	May 16, 1984	Substantially Equivalent	HI CHEM, INC.
K841050	TOTAL BILIRUBIN REAGENT SET	May 01, 1984	Substantially Equivalent	MEDICAL SPECIALTIES, INC.
K840486	TOTAL BILIRUBIN REAGENT	Apr 25, 1984	Substantially Equivalent	SOMAS MEDICAL INDUSTRIES, INC.
K840880	EKTACHEM CLINICAL CHEM. SLIDES	Apr 18, 1984	Substantially Equivalent	EASTMAN KODAK COMPANY
K840779	NEONATAL BILIRUBIN REAGENT	Apr 13, 1984	Substantially Equivalent	AMERICAN DADE
K840777	DIRECT BILIRUBIN REAGENT	Apr 05, 1984	Substantially Equivalent	AMERICAN DADE
K840606	EKTACHEM CLINICAL CHEM. SLIDES	Apr 04, 1984	Substantially Equivalent	EASTMAN KODAK COMPANY
K840111	TOTAL BILIRUBIN	Mar 19, 1984	Substantially Equivalent	FISHER SCIENTIFIC CO., LLC.
K840564	LIQUI ZYME TOTAL BILIRUBIN REAGENT	Mar 09, 1984	Substantially Equivalent	AMERICAN RESEARCH PRODUCTS CO.
K832942	TOTAL & DIRECT BILIRUBIN PROCEDURES	Nov 07, 1983	Substantially Equivalent	SANDARE CHEMICAL CO., INC.
K833004	PARAMAX TOTAL BILIRUBIN REAGENT	Oct 14, 1983	Substantially Equivalent	AMERICAN DADE
K832748	COMPUR* EASYTOUCH TOTAL BILIRUBIN	Oct 14, 1983	Substantially Equivalent	WORTHINGTON DIAGNOSTIC SYSTEMS
K832870	DIAZO COLORIMETRY, BILLIRUBIN	Sep 26, 1983	Substantially Equivalent	POINTE SCIENTIFIC, INC.
K832357	ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK	Sep 01, 1983	Substantially Equivalent	E.I. DUPONT DE NEMOURS & CO., INC.
K832236	SIGMA PROCEDURE #550 DETERM. BILIRUB	Aug 31, 1983	Substantially Equivalent	SIGMA CHEMICAL CO.
K831844	DIRECT BILIRUBIN REAGENT	Jul 18, 1983	Substantially Equivalent	GILFORD DIAGNOSTICS
K831843	GILCHEM TOTAL BILIRUBIN REAGENT	Jul 18, 1983	Substantially Equivalent	GILFORD DIAGNOSTICS
K830714	TOTAL BILIRUBIN REAGENT	Apr 06, 1983	Substantially Equivalent	HI CHEM, INC.
K821873	ULTRACHEM T-BILI	Jul 14, 1982	Substantially Equivalent	HARLECO DIAGNOSTICS
K821197	TOTAL BILIRUBIN REAGENT SET	Jul 13, 1982	Substantially Equivalent	OMEGA MEDICAL ELECTRONICS
K821462	ULTRACHEM T-BILI, #64971	Jun 01, 1982	Substantially Equivalent	EMD CHEMICALS INC.
K820714	DOW BILIRUBIN(DIRECT) DETERMINATION	Apr 01, 1982	Substantially Equivalent	THE DOW CHEMICAL CO.
K820675	BILIRUBIN(TOTAL) DETERMINATION CTMS	Apr 01, 1982	Substantially Equivalent	THE DOW CHEMICAL CO.
K812841	TOTAL & DIRECT BILIRUBIN REAGENT SET	Nov 27, 1981	Substantially Equivalent	ANCO MEDICAL REAGENTS & ASSOC.
K812784	BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD	Oct 20, 1981	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K812754	BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN	Oct 19, 1981	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K811881	KING DIAGNOSTICS TOTAL BILIRUBIN TEST	Jul 23, 1981	Substantially Equivalent	KING DIAGNOSTICS, INC.
K810055	STANBIO BILIRUBIN TEST SET	Feb 02, 1981	Substantially Equivalent	STANBIO LABORATORY
K802630	CAFFEINE REAGENT DIAZO COLORIMETRY	Nov 26, 1980	Substantially Equivalent	AMERICAN MONITOR CORP.
K802154	REAGENTS USED-QUAN. MEASURE OF SERUM	Oct 10, 1980	Substantially Equivalent	PANMED, INC.
K801117	COBAS TOTAL BILIRUBIN REAGENT & DILUENT	Jun 09, 1980	Substantially Equivalent	ROCHE ANALYTICAL INSTRUMENTS, INC.
K800686	REAGENT FOR DETERM. DIRECT BILIRUBIN	May 28, 1980	Substantially Equivalent	DIAGNOSTIC SOLUTIONS, INC.
K800675	REAGENTS FOR DETERM. TOTAL BILIRUBIN	May 28, 1980	Substantially Equivalent	DIAGNOSTIC SOLUTIONS, INC.
K792465	CONNECTICUT DIAGNOSTICS, LTS. DIRECT	Dec 18, 1979	Substantially Equivalent	CONNECTICUT DIAGNOSTICS, LTD.
K792415	ELVI TOTAL BILIRUBIN & FRACTIONS	Dec 07, 1979	Substantially Equivalent	VOLU SOL MEDICAL INDUSTRIES
K792411	ELVI TOTAL BILIRUBIN & FRACTIONS	Dec 06, 1979	Substantially Equivalent	VOLU SOL MEDICAL INDUSTRIES
K792338	DONNECT. DIAG. TOTAL BILIRUBIN REAGENTS	Dec 06, 1979	Substantially Equivalent	CONNECTICUT DIAGNOSTICS, LTD.
K790608	BL BILIRUBINOMETER	Jun 15, 1979	Substantially Equivalent	ADVANCED INSTRUMENTS, INC.
K790578	GAMMA SMAC REAGENTS	May 15, 1979	Substantially Equivalent	GAMMA ENTERPRISES, INC.
K781921	BILIRUBIN, DINGLE VALVE DPD	Jan 03, 1979	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K781610	BILIRUBIN DETERMINTAITON IN SERUM	Oct 24, 1978	Substantially Equivalent	FISHER SCIENTIFIC CO., LLC.
K780826	BILIRUBIN RAPID STAT KIT	May 26, 1978	Substantially Equivalent	PIERCE CHEMICAL CO.
K780524	ULTRACHEM T-BILI 64971 GILFORD 3500	May 19, 1978	Substantially Equivalent	HARLECO
K771840	TOTAL BILIRUBIN	Oct 19, 1977	Substantially Equivalent	GAMMA ENTERPRISES, INC.
K771621	MULTISTAT III, TOTAL BILIRUBIN TEST	Sep 13, 1977	Substantially Equivalent	INSTRUMENTATION LABORATORY CO.
K771092	UNIPAK TOTAL & DIRECT BILIRUBIN	Jul 21, 1977	Substantially Equivalent	HARLECO
K771089	UNIPAK TOTAL BILIRUBIN	Jul 21, 1977	Substantially Equivalent	HARLECO
K770458	BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR.	May 10, 1977	Substantially Equivalent	ICN PHARMACEUTICALS, INC.
K770121	MANUEL BILIRUBIN REAGENT SET	Jan 31, 1977	Substantially Equivalent	HARLECO
K761218	AUTO TOTAL BILIRUBIN REAGENT	Dec 21, 1976	Substantially Equivalent	HARLECO
K761027	AUTO-TOTAL BILIRUBIN REAG FOR GILFORD AN	Nov 30, 1976	Substantially Equivalent	HARLECO
K760409	SODIUM NITRITE	Nov 02, 1976	Substantially Equivalent	J.T. BAKER CHEMICAL CO.
K760408	POTASSIUM SODIUM TARTRATE	Nov 02, 1976	Substantially Equivalent	J.T. BAKER CHEMICAL CO.
K760479	REAGENT, TOTAL BILIRUBIN DETERMINATION	Oct 29, 1976	Substantially Equivalent	SIMMLER & SON, INC.
K760407	SULFANILIC ACID	Oct 29, 1976	Substantially Equivalent	J.T. BAKER CHEMICAL CO.
K760406	CAFFEINE DILUENT	Oct 29, 1976	Substantially Equivalent	J.T. BAKER CHEMICAL CO.

FEI Numbers

This FDA classification entry is associated with 52 FEI numbers. Click on an entry to view related FDA registrations.

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2050010: 124 registrations

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2250051: 152 registrations

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2517506: 354 registrations

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3001451797: 67 registrations

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3002806559: 387 registrations

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