OCC

Respiratory Virus Panel Nucleic Acid Assay System

Product code

OCC

Device name

Respiratory Virus Panel Nucleic Acid Assay System

Device class

Class 2

21 CFR

21 CFR 866.3980

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

3

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses: Influenza A and Influenza B, Influenza A subtype H1 and Influenza A subtype H3, Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus.

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

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

Last three years. Most recent: 2026-05-01.

2 summaries are archived here for direct download.