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System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

FDA product code PEX · 3 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3361
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2013-11-21 – 2017-07-26

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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