Device type
Multi-Analyte Respiratory Virus Antigen Detection Test
Product code SCA · Class II · 21 CFR 866.3987 · Microbiology
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.
Recent 510(k)s
Oct 14, 2026
K262432
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test
CorDx, Inc.
- SCA
- Class II
Recent recalls
No recalls in the archive for SCA.