System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Medical specialty
Microbiology
Device class
2
Regulation number
866.3361
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.