MOJ
2023-03-30
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)
FDA product code MOJ · 3 cleared devices
Class 2
Clinical Toxicology
- Regulation
- 21 CFR 862.3350
- Review panel
- TX
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1995-05-02 – 2023-03-30
MOJ
1995-07-31
COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS
View details →
MOJ
1995-05-02
TDX(R)/TDXFLX(R) FREE PHENYTOIN II
View details →No matching devices.
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