Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

FDA product code QQX · Class II (moderate risk) · 21 CFR 866.3981 · Microbiology

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.

11510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K243396Aptima SARS-CoV-2 AssayQQX · Traditional Hologic, Inc.02/13/2025SE
K240867cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 SystemsQQX · Traditional Roche Molecular Systems, Inc.02/11/2025SE
K242109Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX · Dual Track Cepheid®01/15/2025SE
K241580Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)QQX · Traditional Abbott Molecular12/06/2024SE
K233453Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR KitQQX · Traditional Life Technologies Corporation07/10/2024SE
K230440Xpert® Xpress CoV-2 plusQQX · Traditional Cepheid®10/13/2023SE
K231306cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 SystemsQQX · Special Roche Molecular Systems, Inc.06/01/2023SE
K213804cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 SystemsQQX · Traditional Roche Molecular Systems, Inc.10/22/2022SE
K212147Simplexa COVID-19 DirectQQX · Traditional Diasorin Molecular, LLC09/13/2022SE
K221460BioFire COVID-19 Test 2QQX · Special Biofire Defense, LLC07/25/2022SE
K211079BioFire COVID-19 Test 2QQX · Traditional Biofire Defense, LLC11/01/2021SE