QAA

Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

Product code

QAA

Device name

Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

Device class

Class 2

21 CFR

21 CFR 866.3376

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).