FDA.reportPublic FDA data

VITEK® 2 AST-GP75

Primary DI
03573026530679
Brand
VITEK® 2 AST-GP75
Company
BIOMERIEUX , INC.
Model
VITEK® 2 AST-GP75
Device description
VITEK ® 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 to determine susceptibility of Staphylococcus spp., Enterococcus spp., & S. agalactiae
Published
2017-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short IncubationMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032399000
K032766000
K050976000
K053097000
K072668000
K072695000
K080201000
K091126000
K093076000
K122547000
N50510085
N50510101
N50510102
N50510106
N50510108
N50510111
N50510113
N50510116
N50510117

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032399000VITEK 2 GRAM POSITIVE MOXIFLOXACINbioMerieux, Inc.2003-09-10LON
K032766000VITEK 2 GRAM POSITIVE LINEZOLIDbioMerieux, Inc.2003-10-31LON
K050976000VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLEbioMerieux, Inc.2005-05-23LON
K053097000VITEK 2 GRAM POSITIVE CEFOXITIN SCREENbioMerieux, Inc.2005-12-14LON
K072668000VITEK 2 GRAM POSITIVE VANCOMYCINbioMerieux, Inc.2007-10-15LON
K072695000VITEK 2 GRAM POSITIVE TIGECYCLINEbioMerieux, Inc.2007-11-16LON
K080201000VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCEbioMerieux, Inc.2008-04-30LON
K091126000VITEK 2 GRAM POSITIVE DAPTOMYCINbioMerieux, Inc.2009-06-18LON
K093076000VITEK 2 GRAM POSITIVE DOXCYCLINEbioMerieux, Inc.2010-10-21LON
K122547000GRAM POSTITVE CLINDAMYCINbioMerieux, Inc.2012-10-15LON
N50510085VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDBiomerieux Vitek, Inc.1978-03-02LTW
N50510101VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDBiomerieux Vitek, Inc.1978-03-02LTW
N50510102VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDBiomerieux Vitek, Inc.1978-03-02LTW
N50510106VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDBiomerieux Vitek, Inc.1978-03-02LTW
N50510108VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDBiomerieux Vitek, Inc.1978-03-02LTW
N50510111VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDBiomerieux Vitek, Inc.1978-03-02LTW
N50510113VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDBiomerieux Vitek, Inc.1978-03-02LTW
N50510116VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDBiomerieux Vitek, Inc.1978-03-02LTW
N50510117VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDBiomerieux Vitek, Inc.1978-03-02LTW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026437183PackageGS120In Commercial Distribution
03573026530679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026437183035730264371833573026437183
03573026530679035730265306793573026530679

GMDN Terms#

Term, Definition table
TermDefinition
General-microorganism antimicrobial susceptibility culture medium IVDA non-selective culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on general microorganisms isolated from a clinical specimen.

Storage And Handling#

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

Regulatory Flags#

DUNS number
086785110
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03573026628116VITEK® 2 AST-XN19VITEK® 2 AST-XN192022-04-15
03573026618285VITEK10.02025-05-15
03573026612047BACT/ALERT® BPABACT/ALERT® BPA2020-06-26
03573026614157BACT/ALERT® BPNBACT/ALERT® BPN2020-06-26
03573026613914VITEK® 2 Knowledge base update 09.039.032022-04-11
03573026615499VITEK® COMPACT PRO4234652025-05-15
03573026222222VITEK® 2 DENSICHEK® Plus Standards Kit212552016-11-30
03573026609399VITEK® 2 Software 09.029.02.02019-06-12
03573026530808VITEK® 2 AST-GP74VITEK® 2 AST-GP742017-01-09
03573026595722BACT/ALERT® PFBACT/ALERT® PF2020-04-22
03573026595906BACT/ALERT® FABACT/ALERT® FA2020-04-23
03573026595920BACT/ALERT® FNBACT/ALERT® FN2020-04-23
03573026222239DENSICHEK® Plus212502016-11-30
03573026530914VITEK® 2 AST-GN68VITEK® 2 AST-GN682017-01-09
03573026647780VITEK® 2 AST-N816VITEK® 2 AST-N8162025-11-21
03573026638887VITEK® REVEAL™ BC GN02-ASTVITEK® REVEAL™ BC GN02-AST2024-10-09
03573026613112PREVI™ Isola Applicator CartrigePREVI™ Isola Applicator Cartrige2020-06-26
03573026145842VITEK®227222R2016-09-14
03573026553968VITEK®28.012017-01-03
03573026619060VITEK®29.01.12019-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350136800344ASTar BC G- Kit softwareQ-Linea ABLON2026-05-12
30382904490851NMIC-315BECTON, DICKINSON AND COMPANYLON2026-01-29
00382904490850NMIC-315BECTON, DICKINSON AND COMPANYLON2026-01-29
15099590799717MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799724MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799755MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799762MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799243MicroScanBeckman Coulter, Inc.LON2025-12-08
15099590799250MicroScanBeckman Coulter, Inc.LON2025-12-08
15099590807146MicroScanBeckman Coulter, Inc.LON2025-12-08
03573026647780VITEK® 2 AST-N816BIOMERIEUX , INC.LON2025-11-21
00860012092109LifeScale ASTAffinity Biosensors, LLCLON2025-10-14
00860012092116LSGNAffinity Biosensors, LLCLON2025-10-14
00860012092123LifeScale SensorAffinity Biosensors, LLCLON2025-10-14
03573026615499VITEK® COMPACT PROBIOMERIEUX , INC.LON2025-05-15
03573026618285VITEKBIOMERIEUX , INC.LON2025-05-15
30382904490820NMIC-312BECTON, DICKINSON AND COMPANYLON2025-03-20
30382904490837NMIC/ID-313BECTON, DICKINSON AND COMPANYLON2025-03-20
00382904449575BDXpert™ SystemBECTON, DICKINSON AND COMPANYLON2025-03-20
00382904490829NMIC-312BECTON, DICKINSON AND COMPANYLON2025-03-20
00382904490836NMIC/ID-313BECTON, DICKINSON AND COMPANYLON2025-03-20
00850031114029Selux AST Gram Negative PanelSelux Diagnostics, Inc.LON2024-12-20
00850031114142Selux Seaparator Reagent KitSelux Diagnostics, Inc.LON2024-12-20
00195893563760Selux AST SystemSelux Diagnostics, Inc.LON2024-12-20
00850031114005Bulk Analyzer Reagent PackSelux Diagnostics, Inc.LON2024-12-20
10850031114026Selux AST Gram Negative PanelSelux Diagnostics, Inc.LON2024-12-20
00850031114036AST InoculatorSelux Diagnostics, Inc.LON2024-12-20
00850031114043AST AnalyzerSelux Diagnostics, Inc.LON2024-12-20
00850031114067PBC Separator with Selux AST SystemSelux Diagnostics, Inc.LON2024-12-20
10850031114149Selux Seaparator Reagent KitSelux Diagnostics, Inc.LON2024-12-20