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U.S. Department of Health and Human Services

Product Classification
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Device system, mass spectrometry, maldi tof, microorganism identification, cultured isolates
Regulation Description Mass spectrometer system for clinical use for the identification of microorganisms.
Definition A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.
Physical State In vitro diagnostic device
Technical Method Matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) mass spectrometry
Target Area Identification of microorganisms cultured from human specimens
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePEX
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3361
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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