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11 FDA 510(k) clearances · Product code

FDA profile

Official device name

Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3981

Medical specialty

Microbiology

FDA 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.

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