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
1990-04-25
CIG
1990-04-16
AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD)
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CIG
1990-03-19
SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX
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CIG
1990-03-15
OLYMPUS DIRECT BILIRUBIN
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CIG
1990-02-27
DIRECT BILIRUBIN REAGENT
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CIG
1990-02-27
COBAS READY TOTAL BILIRUBIN REAGENT
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CIG
1989-11-14
TOTAL BILIRUBIN L.F.
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CIG
1989-10-17
SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406
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CIG
1989-10-17
SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407
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CIG
1989-08-15
CLINISTAT TOTAL BILIRUBIN REAGENT TEST
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CIG
1989-08-11
DIRECT BILIRUBIN REAGENT
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CIG
1989-07-20
TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS
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CIG
1989-06-19
DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.
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CIG
1989-05-10
DIRECT BILIRUBIN FOR CONTINUOUS FLOW
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CIG
1989-04-04
TOTAL BILIRUBIN FOR CONTINUOUS FLOW
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CIG
1989-03-06
TOTAL BILIRUBIN REAGENT, CONCENTRATED
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CIG
1989-01-30
DIRECT BILIRUBIN TEST CATALOG NO. SR1008
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CIG
1989-01-30
TOTAL BILIRUBIN TEST CATALOG NO. SR1007
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CIG
1989-01-27
UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON.
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CIG
1988-12-15
TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS
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CIG
1988-08-03
VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM
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CIG
1988-08-02
DIAZO, COLORIMETRIC BILIRUBIN
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CIG
1988-06-07
TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN
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CIG
1988-06-07
BILIRUBIN (DIRECT)
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CIG
1988-05-27
TOTAL BILIRUBIN REAGENT
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CIG
1988-04-28
DIRECT BILIRUBIN PROCEDURE
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CIG
1988-04-05
ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT
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CIG
1988-03-15
DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.
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CIG
1988-03-15
TOTAL BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.
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CIG
1988-03-15
TOTAL BILIRUBIN PROCEDURE RUN ON A DEMAND INSTRU.
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CIG
1988-01-11
BILIRUBIN (TOTAL)
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CIG
1987-11-25
MULTICHEM (R) TOTAL BILIRUBIN
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CIG
1987-11-25
IQ/QCA TOTAL BILIRUBIN
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CIG
1987-11-23
REFLOTRON BILIRUBIN
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CIG
1987-10-02
CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95
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CIG
1987-09-14
EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690
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CIG
1987-08-21
EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604
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CIG
1987-08-21
EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95
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CIG
1987-08-21
VISION(R) TOTAL BILIRUBIN
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CIG
1987-08-19
DIRECT BILIRUBIN REAGENT - ACID DIAZO METHOD
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CIG
1987-08-19
TOTAL BILIRUBIN REAGENT - DMSO METHOD
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CIG
1987-08-13
PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT
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CIG
1987-06-03
BILIRUBIN TESTER
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CIG
1987-05-18
REAGENTS 1263,1273,1284,1425,014301,053583
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CIG
1987-05-14
TOTAL BILIRUBIN REAGENT 1372,1425,1284,1273,053583
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CIG
1986-11-24
BILIRUBIN TOTAL
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CIG
1986-10-24
DIRECT BILIRUBIN PROCEDURE
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CIG
1986-09-26
BILIRUBIN TOTAL DIRECT
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CIG
1986-09-17
TOTAL BILIRUBIN PROCEDURE
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CIG
1986-09-09
BILIFAST
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CIG
1986-08-19
METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM
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CIG
1986-07-01
AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS
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CIG
1986-06-27
TOTAL BILIRUBIN TEST KIT
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CIG
1986-06-25
DIRECT BILIRUBIN PROCEDURE
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CIG
1986-05-29
TOTAL BILIRUBIN PROCEDURE
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CIG
1986-04-24
BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET
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CIG
1986-04-21
BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04
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CIG
1986-04-21
BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02
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CIG
1986-04-03
A-GENT LIQUID TOTAL BILIRUBIN
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CIG
1986-03-17
TOTAL BILIRUBIN REAGENT SET
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CIG
1986-03-05
NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95
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CIG
1986-02-21
DIRECT BILIRUBIN
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CIG
1986-01-14
DIRECT & TOTAL BILIRUBIN SET
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CIG
1985-11-25
IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN
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CIG
1985-05-30
T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL
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CIG
1985-04-03
I-L TEST, DIRECT BILIRUBIN SET
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CIG
1985-04-03
ABBOTT TDT EIA
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CIG
1985-04-01
DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE
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CIG
1985-03-01
DIRECT BILIRUBIN FOR DEMAND ANALYZER
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CIG
1984-09-20
SYSTEMATE D-BILI 67213
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CIG
1984-09-20
SYSTEMATE T-BILI 67212
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CIG
1984-09-07
TOTAL BILIRUBIN TEST
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CIG
1984-09-04
BILIRUBIN ASSAY KIT - TOTAL
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CIG
1984-09-04
BILIRUBIN ASSAY KIT DIRECT
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CIG
1984-08-17
TECHNICON RA-1000 SYS, DIRECT BILIRUBIN
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CIG
1984-08-17
ACA CONJUGATED BILIRUBIN ANALYTICAL
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CIG
1984-06-07
RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT
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CIG
1984-05-30
ELVI 444 BILITRON
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CIG
1984-05-16
DIRECT BILIRUBIN REAGENT
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CIG
1984-05-01
TOTAL BILIRUBIN REAGENT SET
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CIG
1984-04-25
TOTAL BILIRUBIN REAGENT
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CIG
1984-04-18
EKTACHEM CLINICAL CHEM. SLIDES
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CIG
1984-04-13
NEONATAL BILIRUBIN REAGENT
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CIG
1984-04-05
DIRECT BILIRUBIN REAGENT
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CIG
1984-04-04
EKTACHEM CLINICAL CHEM. SLIDES
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CIG
1984-03-19
TOTAL BILIRUBIN
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CIG
1984-03-09
LIQUI ZYME TOTAL BILIRUBIN REAGENT
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CIG
1983-11-07
TOTAL & DIRECT BILIRUBIN PROCEDURES
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CIG
1983-10-14
PARAMAX TOTAL BILIRUBIN REAGENT
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CIG
1983-10-14
COMPUR* EASYTOUCH TOTAL BILIRUBIN
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CIG
1983-09-26
DIAZO COLORIMETRY, BILLIRUBIN
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CIG
1983-09-01
ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK
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CIG
1983-08-31
SIGMA PROCEDURE #550 DETERM. BILIRUB
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CIG
1983-07-18
DIRECT BILIRUBIN REAGENT
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CIG
1983-07-18
GILCHEM TOTAL BILIRUBIN REAGENT
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CIG
1983-04-06
TOTAL BILIRUBIN REAGENT
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CIG
1982-07-14
ULTRACHEM T-BILI
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CIG
1982-07-13
TOTAL BILIRUBIN REAGENT SET
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CIG
1982-06-01
ULTRACHEM T-BILI, #64971
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CIG
1982-04-01
DOW BILIRUBIN(DIRECT) DETERMINATION
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