FDA.reportPublic FDA data

VITEK® MS knowledge base v3.3

Primary DI
03573026628154
Brand
VITEK® MS knowledge base v3.3
Company
BIOMERIEUX SA
Model
3.3
Device description
VITEK® MS knowledge base v3.3
Published
2023-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PEXSystem, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
QBNMass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEXSystem, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured IsolatesMicrobiology2
QBNMass Spectrometry, Maldi Tof, Microorganism Identification, Cultured IsolatesMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162950000
K181412000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162950000VITEK MSbioMerieux, Inc.2017-07-22PEX
K181412000VITEK MSbioMerieux, Inc.2018-12-21QBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026628154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026628154035730266281543573026628154

GMDN Terms#

Term, Definition table
TermDefinition
Microbial identification mass spectrometry system IVDAn assembly of mains electricity (AC-powered) devices intended to be used for the qualitative detection and identification of microbial species (bacteria, fungi) in a clinical specimen using mass spectrometry. It typically consists of a sample handling/preparation unit, a mass spectrometry instrument, and a server with software intended to analyse results and compare the produced spectra with information in a remote database to identify and report the microbial species in the specimen. The system operates with reduced technician involvement and automation of some, but not all, procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276816717
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03573026064532VIDAS® Measles IgG302192019-08-30
03573026064518VIDAS® Varicella-Zoster IgG302172016-08-31
03573026610418VITEK®MSVITEKMS SW v1.0 / FlexPrep v1.02019-04-30
03573026644796VIDAS® Varicella-Zoster IgG30217-012026-01-19
03573026550523ETEST® Tigecycline (TGC)Etest® TIGECYCLINE2016-12-12
03573026584139ID color CatalaseID color Catalase2019-07-19
03573026092009ID color CatalaseID color Catalase2019-07-19
03573026559823THxID™ BRAF1.02017-05-12
03573026121631VIDAS® Quality Control307062019-11-19
B0744000160ASTUTE140 Electronic Quality Control (EQC) Device4000164000162016-08-12
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) Kit5000095000092016-08-12
B0745000110NEPHROCHECK Test Kit 5000115000112016-08-12
B0745000130NEPHROCHECK Liquid Control Kit5000135000132016-08-12
03573026547226ETEST® Ertapenem (ETP)ETEST® Ertapenem (ETP)2016-11-18
03573026547271ETEST® Tobramycin (TM)ETEST® Tobramycin (TM)2016-11-18
03573026547295ETEST® Tigecycline (TGC)ETEST® Tigecycline (TGC)2016-11-18
03573026548674ETEST® Ampicillin/sulbactam (2/1) (AB)ETEST® Ampicillin/sulbactam (2/1) (AB)2016-11-18
03573026549046ETEST® Tetracycline (TC)ETEST® Tetracycline (TC)2016-11-18
03573026549077ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)2016-11-18
03573026547196ETEST® Fosfomycin (FM)ETEST® Fosfomycin (FM)2016-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251204328278MBT Compass HT CABruker Daltonik GmbHQBN2025-11-28
04251204328285MBT HT Sepsityper CA ModuleBruker Daltonik GmbHQBN2025-11-28
04251204328728MBT FAST Shuttle US IVDBruker Daltonik GmbHQBN2025-11-28
03573026637200VITEK® MS SOFTWARE v1.2BIOMERIEUX SAPEX2025-04-29
03573026637200VITEK® MS SOFTWARE v1.2BIOMERIEUX SAQBN2025-04-29
03573026626211VITEK®MSBIOMERIEUX SAQBN2024-03-08
03573026617851VITEK®MSBIOMERIEUX SAQBN2024-03-08
18050148217975Colibrí™ Primary Tube with WaterCOPAN WASP SRLQBN2024-01-31
18052870817966Colibrí™ Primary Tube with SalineCOPAN WASP SRLQBN2024-01-31
58050148217973Colibrí™ Primary Tube with WaterCOPAN WASP SRLQBN2024-01-31
58052870817964Colibrí™ Primary Tube with SalineCOPAN WASP SRLQBN2024-01-31
00382904440633BD Kiestra™ IdentifABECTON, DICKINSON AND COMPANYQBN2023-05-31
08050148218005Colibri Daily Verification KitCOPAN WASP SRLQBN2022-11-15
18050148212864Colibri SpreaderCOPAN WASP SRLQBN2022-11-15
18050148217968Colibrí™ Primary Tube for VITEK 2COPAN WASP SRLQBN2022-11-15
58050148218208Colibrí™COPAN WASP SRLQBN2022-11-15
03573026611422VITEK® MS PRIMEBIOMERIEUX SAQBN2022-04-25
58052870816202Colibrí™ SystemCOPAN WASP SRLQBN2022-01-27
58052870818428Colibrí™ Vision SystemCOPAN WASP SRLQBN2022-01-27
58052870818435Colibrí™ Preparation StationCOPAN WASP SRLQBN2022-01-27
03573026621698VITEK® MS SOFTWARE v1.1BIOMERIEUX SAPEX2021-11-03
03573026621698VITEK® MS SOFTWARE v1.1BIOMERIEUX SAQBN2021-11-03
04251204326182MBT Sepsityper Kit US IVDBruker Daltonik GmbHPEX2021-02-11
04251204326298MBT Galaxy System - US IVDBruker Daltonik GmbHPEX2021-02-11
04251204326304MBT Pilot System - US IVDBruker Daltonik GmbHPEX2021-02-11
04251204326175MALDI Biotyper-BD sirius CA SystemBruker Daltonik GmbHPEX2020-12-09
04251204326311MALDI Biotyper sirius one CA SystemBruker Daltonik GmbHPEX2020-12-09
04251204326359MALDI Biotyper-BD sirius one CA SystemBruker Daltonik GmbHPEX2020-12-09
04251204326168MALDI Biotyper sirius CA SystemBruker Daltonik GmbHPEX2019-07-01
03573026610418VITEK®MSBIOMERIEUX SAPEX2019-04-30