Enzymatic Method, Bilirubin
FDA product code JFM · 11 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
- 1984-09-14 – 2017-03-09
JFM
2017-03-09
JFM
2016-02-16
Direct Bilirubin
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JFM
2016-01-28
Total Bilirubin
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JFM
2007-12-07
ADVIA CHEMISTRY TOTAL BILIRUBIN_2
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JFM
2005-12-30
WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
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JFM
2005-12-30
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
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JFM
2005-12-16
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
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JFM
2005-06-30
DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR
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JFM
1997-04-21
WAKO TOTAL BILIRUBIN V
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JFM
1990-11-20
ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14
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JFM
1984-09-14
DRI-STAT ENZYMATIC BILIRUBIN TEST KIT
View details →No matching devices.
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