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Biothreat Microbial Agent Nucleic Acid Detection Test

FDA product code SGA · 2 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.4000
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-09-30 – 2026-03-30

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.

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