Influenza a and Influenza B Multiplex Nucleic Acid Assay

What Is This Device?

An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral infections if used in conjunction with other clinical and laboratory findings.

What Is FDA Product Code OZE?

Influenza A And Influenza B Multiplex Nucleic Acid Assay is FDA product code OZE, Class 2, 21 CFR 866.3980.

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. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Has Gone Wrong With It?

The FDA has recorded 5 recalls under this product code since 2019. None was by a company in China. The root causes the FDA records most often are Process change control (2) and Process control (1).

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