FDA.reportPublic FDA data

VITEK®MS

Primary DI
03573026617851
Brand
VITEK®MS
Company
BIOMERIEUX SA
Model
VITEK MS
Device description
VITEK MS ready to use reagent for calibration and fine tuning of the VITEK MS instrument
Published
2024-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
QBNMass spectrometry, MALDI TOF, microorganism identification, cultured isolates

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212461000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212461000VITEK MS PRIMEbioMerieux, Inc.2022-03-15QBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026617851PackageGS15In Commercial Distribution
03573026626211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026617851035730266178513573026617851
03573026626211035730266262113573026626211

GMDN Terms#

Term, Definition table
TermDefinition
Mass spectrometry analyser calibration kit IVDA collection of reagents and other associated materials intended to be used to calibrate or verify the performance of a mass spectrometry analyser to ensure its proper function, prior to analysis/processing of clinical samples.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276816717
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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 SAQBN2025-04-29
03573026626211VITEK®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
03573026628154VITEK® MS knowledge base v3.3BIOMERIEUX SAQBN2023-11-14
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 SAQBN2021-11-03