System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
- US Product Code (FDA)
- PEXView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 866.3361View CFR Regulation →
- Medical specialty
- Microbiology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.
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System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.