Pure Global

Biothreat Microbial Agent Nucleic Acid Detection Test

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.

Global Registration Data
Multi-Country Intelligence
Biothreat Microbial Agent Nucleic Acid Detection Test
Immunology Medical Device Type
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Regulatory Classifications

US Regulatory Classifications

SGA

View Product Code Classification

Class 2

21 CFR 866.4000

View CFR Regulation

Immunology

Device Characteristics

No

No

No

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 agentย–associated nucleic acids in human clinical specimens.

Search Keywords

Click to search for similar devices in our global database