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

Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

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

QBN is the FDA product code for Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates, a class II device type, regulated under 21 CFR 866.3378. FDA's definition for this code reads: "The MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification and differentiation of microorganisms cultured from human specimens. The MALDI Biotyper CA System is a qualitative in vitro diagnostic device indicated for...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QBN
Device name
Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
FDA definition
The MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification and differentiation of microorganisms cultured from human specimens. The MALDI Biotyper CA System is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.
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 QBN

By decision year
4 clearances under product code QBN with a decision year between 2018 and 2025, 2018 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QBN by decision year
YearClearances
20182
20221
20251

Applicants with the most clearances

Product code QBN
Applicants holding the most 510(k) clearances under product code QBN
ApplicantClearances
bioMerieux, Inc.2
Bruker Daltonics GmbH & Co. KG1
Bruker Daltonik GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code