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Multiplex Nucleic Acid Detection System For Biothreat Agents

FDA product code QVR · 3 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
2023-03-22 – 2026-08-07

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

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