Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
Medical specialty
Microbiology
Device class
2
Regulation number
866.3378
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
An automated in vitro diagnostic system to prepare colonies of microorganisms grown on solid culture media from human specimens for qualitative identification and differentiation using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS).