FDA product code NAK
System, Test, Biotinidase
Clinical Chemistry·Class 2·21 CFR 862.1118
US regulatory classifications
- US Product Code (FDA)
- NAKView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 862.1118View CFR Regulation →
- Medical specialty
- Clinical Chemistry
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
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About this record
System, Test, Biotinidase 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.