SIA

Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test

Product code

SIA

Device name

Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test

Device class

Class 2

21 CFR

21 CFR 866.3984

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

An over-the-counter molecular multi-analyte respiratory virus detection test is an in vitro diagnostic device for the detection and/or differentiation of respiratory viruses directly from clinical specimens. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments.

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-05-27.

1 summaries are archived here for direct download.