Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
QQV · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3378
Classification
FDA Product Code
QQV
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3378
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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).