Devices Detecting Influenza A, B, and C Virus Antigens

What Is It?

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.

How Is PSZ Classified?

Devices Detecting Influenza A, B, And C Virus Antigens is FDA product code PSZ, Class 2, 21 CFR 866.3328.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 141 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 5 recalls under this product code since 2017. None was by a company in China. The root causes the FDA records most often are Software Manufacturing/Software Deployment (1) and Process control (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.