FDA product code NTM
Antigen, Inflammatory Response Marker, Sepsis
Microbiology·Class 2·21 CFR 866.3210
US regulatory classifications
- US Product Code (FDA)
- NTMView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 866.3210View CFR Regulation →
- Medical specialty
- Microbiology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma.
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About this record
Antigen, Inflammatory Response Marker, Sepsis is a medical device type in the Microbiology 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.