SCA

12 FDA 510(k) clearances · Product code

FDA profile

Official device name

Multi-Analyte Respiratory Virus Antigen Detection Test

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3987

Medical specialty

Microbiology

FDA definition

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.

Adverse events (MAUDE)

2026: 45
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free