SGA

Biothreat Microbial Agent Nucleic Acid Detection Test

Product code

SGA

Device name

Biothreat Microbial Agent Nucleic Acid Detection Test

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)

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

FDA classification definition

A biothreat microbial agent nucleic acid detection test is a qualitative in vitro diagnostic device for the detection and identification of biothreat microbial agent–associated nucleic acids 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: 2026-03-30.

2 summaries are archived here for direct download.