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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
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 Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3365
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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