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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device coccidioides spp. nucleic acid detection system for respiratory specimens
Definition A Coccidioides spp. nucleic acid detection system for respiratory specimens is a qualitative test for the detection of Coccidioides spp. nucleic acids directly in clinical respiratory specimens from patients with signs and symptoms of coccidioidomycosis and suspicion of infection.
Product CodeQAA
Regulation Number 866.3376
Device Class 2

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