DeviceClearance

Product code QAA— Microbiology

GeneSTAT.MDx Coccidioides Assay

Classification name
Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens
Device class
Class 2
Regulation
21 CFR 866.3376
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QAA under 21 CFR 866.3376, via openFDA

Market context for product code QAA

FDA has cleared 1 device under product code QAA, all in 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QAA

Recent clearances under product code QAA

Data sourced from openFDA. This site is unofficial and independent of the FDA.