QQV

4 FDA 510(k) clearances · Product code

FDA profile

Official device name

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

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3378

Medical specialty

Microbiology

FDA 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).

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