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U.S. Department of Health and Human Services

Product Classification
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Device direct blood bacterial nucleic acid detection system
Regulation Description Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.
Definition Amplification, detection and identification of microbial pathogens directly from whole blood specimens
Physical State The direct blood bacterial nucleic acid detection system consists of reagents and disposables. The associated instrumentation performs the amplification of bacterial nucleic acid, detects the amplified products and reports results.
Technical Method A multiplexed nucleic acid amplification assay that amplifies and detects bacterial DNA in whole blood specimens
Target Area Nucleic acids of bacteria
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQBX
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3960
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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