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Multiplex Nucleic Acid Detection System For Biothreat Agents

Multiplex Nucleic Acid Detection System For Biothreat Agents 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
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Multiplex Nucleic Acid Detection System For Biothreat Agents
Immunology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QVR

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Class 2

21 CFR 866.4000

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Immunology

Device Characteristics

No

No

No

Not Eligible

Definition

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