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C. Difficile Nucleic Acid Amplification Test Assay

C. Difficile Nucleic Acid Amplification Test 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.

Global Registration Data
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C. Difficile Nucleic Acid Amplification Test Assay
Microbiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OMN

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Class 1

21 CFR 866.2660

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Microbiology

Device Characteristics

No

No

No

Not Eligible

Definition

In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.