NHY

Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus

Product code

NHY

Device name

Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus

Device class

Class 1

21 CFR

21 CFR 866.3480

Medical specialty

Microbiology

Marketing pathway

510(K)

Flag

Third-party review eligible

FDA classification definition

These reagents are nucleic acid primers and probes for the amplification and identification of Respiratory Syncytial virus directly from clinical specimens. The identification aids in the diagnosis of influenza and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera.

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