QAAClass II

Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

21 CFR 866.3376 / Microbiology

QAA is the FDA product code for Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens, a class II device type, regulated under 21 CFR 866.3376. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2017-11-29, and no recalls.

Classification record

Product code: QAA
Device name: Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens
FDA 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.
Regulation: 21 CFR 866.3376
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code QAA

By decision year

1 clearance under product code QAA with a decision year between 2017 and 2017, 2017 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code QAA by decision year
Year	Clearances
2017	1

Applicants with the most clearances

Product code QAA

Applicants holding the most 510(k) clearances under product code QAA
Applicant	Clearances
Dxna, LLC	1

Companies listing this code with FDA

Companies whose registered establishments list this code

IMMY, Inc.

Recent clearances

Product code QAA

DEN170041Class IIGeneSTAT.MDx Coccidioides AssayDxna, LLC / cleared 2017-11-29

Recent recalls

Product code QAA

FDA records show no recalls under product code QAA.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)