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FDA product code MOJ

Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)

Clinical ToxicologyClass 221 CFR 862.3350
Verified
US regulatory classifications
US Product Code (FDA)
MOJ
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 862.3350
View CFR Regulation
Medical specialty
Clinical Toxicology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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01FPIA02Phenytoin assay03Diphenylhydantoin04Drug level05Therapeutic drug06TDM test07Immunoassay08Diagnostic kit09Antiepileptic drug10Serum level
About this record

Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free) is a medical device type in the Clinical Toxicology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.