FDA product code SGA

Biothreat Microbial Agent Nucleic Acid Detection Test

Immunology·Class 2·21 CFR 866.4000
US regulatory classifications
US Product Code (FDA)
SGA
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.4000
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Medical specialty
Immunology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Biothreat Microbial Agent Nucleic Acid Detection Test is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.