QQV — Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry Class II

FDA Device Classification

Classification Details

Product Code
QQV
Device Class
Class II
Regulation Number
866.3378
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

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).

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K222563becton, dickinson andBD Kiestra IdentifAAugust 31, 2023
K223245copan waspColibríMarch 20, 2023
K193138copan waspColibri SystemDecember 27, 2021
K191964becton, dickinson andBD Kiestra IdentifANovember 3, 2021