QVR

Multiplex Nucleic Acid Detection System For Biothreat Agents

Product code

QVR

Device name

Multiplex Nucleic Acid Detection System For Biothreat Agents

Device class

Class 2

21 CFR

21 CFR 866.4000

Medical specialty

Immunology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens

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

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-08-07.

2 summaries are archived here for direct download.