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U.S. Department of Health and Human Services

Product Classification
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Device automated antimicrobial susceptibility test system for positive blood culture samples
Definition Automated system that performs antimicrobial susceptibility testing using positive blood culture samples
Physical State In vitro diagnostic device
Technical Method Antimicrobial susceptibility testing of microbes detected in positive blood cultures
Target Area For antimicrobial susceptibility testing using positive blood cultures
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeSAN
Premarket Review Office of In Vitro Diagnostics (OHT7)
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		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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