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U.S. Department of Health and Human Services

Product Classification
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Device multiplex nucleic acid detection system for biothreat agents
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
Physical State Multiplex nucleic acid detection systems are in vitro diagnostic devices that include reagents and associated instrumentation for detection and identification of biothreat nucleic acids from human clinical specimens
Technical Method A qualitative in vitro diagnostic assay that detects and identifies nucleic acids from multiple biothreat pathogens
Target Area Whole blood specimens
Regulation Medical Specialty Immunology
Review Panel Microbiology
Product CodeQVR
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.4000
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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