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Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

FDA product code QBN · 3 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3378
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2018-12-21 – 2025-08-13

The MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification and differentiation of microorganisms cultured from human specimens. The MALDI Biotyper CA System is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.

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