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U.S. Department of Health and Human Services

Product Classification
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Device gram-negative bacteria and associated resistance markers
Regulation Description Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
Definition A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.
Physical State Reagent kit
Technical Method Multiplexed nucleic acid-based assay
Target Area N/A
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePEN
Premarket Review Office of In Vitro Diagnostics (OHT7)
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
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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