510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QQVClass II

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

21 CFR 866.3378 / Microbiology
FDA source (opens on fda.gov)

QQV is the FDA product code for Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry, a class II device type, regulated under 21 CFR 866.3378. FDA's definition for this code reads: "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)". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QQV
Device name
Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
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).
Regulation
21 CFR 866.3378
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code QQV

By decision year
4 clearances under product code QQV with a decision year between 2021 and 2023, 2021 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QQV by decision year
YearClearances
20212
20232

Applicants with the most clearances

Product code QQV
Applicants holding the most 510(k) clearances under product code QQV
ApplicantClearances
Becton Dickinson & Co2
Copan WASP2

Companies listing this code with FDA

Companies whose registered establishments list this code