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Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

FDA product code QQV · 4 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
2021-11-03 – 2023-08-31

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).

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