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U.S. Department of Health and Human Services

Product Classification
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Device c. difficile toxin gene amplification assay
Regulation Description Clostridium difficile toxin gene amplification assay.
Definition Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.
Physical State Not applicable
Technical Method Uses amplification technology to detect toxin genes of C. difficile
Target Area Not applicable
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOZN
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3130
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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