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Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test

FDA product code SIA · 1 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
2026-05-27 – 2026-05-27

An over-the-counter molecular multi-analyte respiratory virus detection test is an in vitro diagnostic device for the detection and/or differentiation of respiratory viruses directly from clinical specimens. 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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