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C. Difficile Toxin Gene Amplification Assay

FDA product code OZN · 16 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3130
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2012-12-05 – 2026-08-28

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

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