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U.S. Department of Health and Human Services

Product Classification
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Device mass spectrometry, microorganism identification, blood culture
Definition Blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system with organisms subsequently identified by spectrometry.
Physical State In vitro diagnostic device
Technical Method Spectrometry
Target Area Identification and differentiation of microorganisms in blood culture samples identified as positive by a continuous monitoring blood culture system
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQNJ
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3378
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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