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U.S. Department of Health and Human Services

Product Classification

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Device gram-positive bacteria and their resistance markers
Regulation Description Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
Definition A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.
Physical State blood
Technical Method Multiplexed DNA hybridization array
Target Area Systemic
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePAM
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3365
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible