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Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

Microbiology · 21 CFR 866.3376

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.

MDR events0All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances1All time

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510(k) clearances

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