FDA product code OZN
C. Difficile Toxin Gene Amplification Assay
Microbiology·Class 2·21 CFR 866.3130
US regulatory classifications
- US Product Code (FDA)
- OZNView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 866.3130View CFR Regulation →
- Medical specialty
- Microbiology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.
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About this record
C. Difficile Toxin Gene Amplification Assay 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.