PSZ

Devices Detecting Influenza A, B, And C Virus Antigens

Product code

PSZ

Device name

Devices Detecting Influenza A, B, And C Virus Antigens

Device class

Class 2

21 CFR

21 CFR 866.3328

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

4

Summaries archived here

4 (direct download)

510(k) clearances (all years, FDA)

72 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2026-01-15.

4 summaries are archived here for direct download.