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Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA product code QWB · 2 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3984
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-11-28 – 2026-08-07

An over-the-counter molecular test to detect SARS-CoV-2 is an in vitro diagnostic device for the detection of SARS-CoV-2 in clinical specimens to aid in the diagnosis of SARS-CoV-2 infection. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments.

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