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U.S. Department of Health and Human Services

Product Classification
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Device automated system for sample preparation and identification of microorganisms from cultured isolates by mass spectrometry
Definition An automated in vitro diagnostic system to prepare colonies of microorganisms grown on solid culture media from human specimens for qualitative identification and differentiation using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS).
Physical State In vitro diagnostic device
Technical Method Matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) microorganism identification
Target Area Identification and differentiation of microorganisms cultured from human specimens
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQQV
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
Third Party Review Not Third Party Eligible
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