510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN170041Unknown

GeneSTAT.MDx Coccidioides Assay

Dxna, LLC, St George UT / Direct, Unknown
FDA source (opens on fda.gov)

DEN170041 is the FDA 510(k) clearance record for GeneSTAT.MDx Coccidioides Assay, a class II device, cleared for Dxna, LLC on under FDA product code QAA (Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens). FDA's definition for product code QAA 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...". FDA records list one 510(k) clearance for Dxna, LLC. As of , FDA records show no recalls naming DEN170041.

Clearance record

Decision date
Received
(120 days to decision)
Product code
QAA Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens
Regulation
21 CFR 866.3376
Device class
Class II
Review panel
Microbiology
Applicant
Dxna, LLC 180 N 300 E, St George UT
Third party review
No

Clearances, product code QAA

Trailing 12 months

FDA records hold no clearances under product code QAA in the trailing twelve months.

FDA records show no clearances under product code QAA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QAA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260