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FDA PRODUCT CODE · CLASS II

OZN — C. Difficile Toxin Gene Amplification Assay

Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.

DEVICE CLASS
Class II
REGULATION
21 CFR 866.3130
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

K243730Cepheid® · 510k2025-02-28

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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