Pure Global AI
FDA product code OZN

C. Difficile Toxin Gene Amplification Assay

MicrobiologyClass 221 CFR 866.3130
Verified
US regulatory classifications
US Product Code (FDA)
OZN
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.3130
View 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.