Product Classification

• Device: biothreat microbial agent nucleic acid detection test
• 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.
• Physical State: Reagents and associated instrumentation for detection and identification of biothreat microbial agent–associated nucleic acids in human clinical specimens.
• Technical Method: A qualitative in vitro diagnostic assay that detects and identifies biothreat microbial agent–associated nucleic acids
• Target Area: Human whole blood or other clinical specimens
• Regulation Medical Specialty: Immunology
• Review Panel: Microbiology
• Product Code: SGA
• Premarket Review: Division of Microbiology Devices (DMD); 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