Device type
Devices Detecting Influenza A, B, And C Virus Antigens
Product code PSZ · Class II · 21 CFR 866.3328 · Microbiology
An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.
Recent 510(k)s
Sep 4, 2026
K254262
Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA
Ortho Clinical Diagnostics Inc. (QuidelOrtho)
- PSZ
- Class II
Recent recalls
No recalls in the archive for PSZ.