QAA · Class II · 21 CFR 866.3376

FDA Product Code QAA: Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

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.

Leading manufacturers include Dxna, LLC.

1
Total
0
Cleared
120d
Avg days
2017
Since

FDA 510(k) Cleared Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens Devices (Product Code QAA)

1 devices
1–1 of 1

About Product Code QAA - Regulatory Context