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U.S. Department of Health and Human Services

Product Classification

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Device positive blood culture identification and ast kit
Definition Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets.
Physical State In vitro diagnostic device
Technical Method Direct Fluorescence in situ hybridization (FISH) identification and antimicrobial susceptibility testing (AST) of microbes growing in positive blood cultures
Target Area Direct identification and antimicrobial susceptibility testing of microbes in positive blood cultures
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePRH
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.1650
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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