FDA product code PDS
Amniotic Fluid Protein Immunoassay
Clinical Chemistry·Class 1·21 CFR 862.1550
US regulatory classifications
- US Product Code (FDA)
- PDSView Product Code Classification →
- US Risk Class (FDA)
- Class 1
- US Regulation (CFR)
- 21 CFR 862.1550View CFR Regulation →
- Medical specialty
- Clinical Chemistry
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
Definition
To detect specified amniotic fluid proteins in cervicovaginal samples
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About this record
Amniotic Fluid Protein Immunoassay is a medical device type in the Clinical Chemistry 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.