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Multi-Analyte Respiratory Virus Antigen Detection Test

FDA product code SCA · 11 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3987
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-01-13 – 2026-07-10

A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport.

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