QQX

Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

Product code

QQX

Device name

Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

Device class

Class 2

21 CFR

21 CFR 866.3981

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

6

Summaries archived here

6 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

A device to detect and identify nucleic acid targets in respiratory specimens from SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs and symptoms of respiratory infections by their healthcare providers. The device is intended to aid in the diagnosis of COVID-19 in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.

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

510(k) clearances, last 3 years (6)

Last three years. Most recent: 2025-02-13.

6 summaries are archived here for direct download.