OEP

Influenza A Virus Subtype Differentiation Nucleic Acid Assay

Product code

OEP

Device name

Influenza A Virus Subtype Differentiation Nucleic Acid Assay

Device class

Class 2

21 CFR

21 CFR 866.3980

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture. Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses. Also, it aids in the presumptive laboratory identification of influenza a virus subtypes to provide epidemiological information on influenza.

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