FDA.reportPublic FDA data

VITEK® 2 AST-XN19

Primary DI
03573026628116
Brand
VITEK® 2 AST-XN19
Company
BIOMERIEUX , INC.
Model
VITEK® 2 AST-XN19
Device description
VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli
Published
2022-04-15
Public version status
Update
Distribution status
Not 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
LTTPanels, test, susceptibility, antimicrobial
LTWSusceptibility test cards, antimicrobial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short IncubationMicrobiology2
LTTPanels, Test, Susceptibility, AntimicrobialMicrobiology2
LTWSusceptibility Test Cards, AntimicrobialMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040845000
K072038000
K110106000
K121546000
K152075000
K161217000
K161437000
K163563000
K183551000
K193572000
N50510082
N50510097
N50510107
N50510118
N50510124
N50510127

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040845000VITEK 2 ESBL TESTbioMerieux, Inc.2004-06-08LON
K072038000VITEK 2 GRAM NEGATIVE LEVOFLOXACINbioMerieux, Inc.2007-09-12LON
K110106000VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLEbioMerieux, Inc.2011-11-30LON
K121546000VITEK 2 GRAM NEGATIVE DOXYCYCLINEbioMerieux, Inc.2012-11-20LON
K152075000VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)bioMerieux, Inc.2016-04-15LON
K161217000VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)bioMerieux, Inc.2017-01-12LON
K161437000VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)bioMerieux, Inc.2017-02-16LON
K163563000VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)bioMerieux, Inc.2017-03-13LON
K183551000VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)bioMerieux, Inc.2019-03-07LON
K193572000VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)bioMerieux, Inc.2020-03-13LON
N50510082VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDBiomerieux Vitek, Inc.1978-03-02LTW
N50510097VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDBiomerieux Vitek, Inc.1978-03-02LTW
N50510107VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDBiomerieux Vitek, Inc.1978-03-02LTW
N50510118VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDBiomerieux Vitek, Inc.1978-03-02LTW
N50510124VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDBiomerieux Vitek, Inc.1978-03-02LTW
N50510127VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDBiomerieux Vitek, Inc.1978-03-02LTW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026628123PackageGS120Not in Commercial Distribution
03573026628116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026628123035730266281233573026628123
03573026628116035730266281163573026628116

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
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
03573026641320VITEK® 2 AST-N815VITEK® 2 AST-N8152024-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30382904490851NMIC-315BECTON, DICKINSON AND COMPANYLON2026-01-29
15099590798970MicroScanBeckman Coulter, Inc.LTT2025-12-08
15099590798970MicroScanBeckman Coulter, Inc.LTW2025-12-08
15099590798987MicroScanBeckman Coulter, Inc.LTT2025-12-08
15099590798987MicroScanBeckman Coulter, Inc.LTW2025-12-08
15099590798994MicroScanBeckman Coulter, Inc.LTW2025-12-08
15099590798994MicroScanBeckman Coulter, Inc.LTT2025-12-08
15099590799007MicroScanBeckman Coulter, Inc.LTT2025-12-08
15099590799007MicroScanBeckman Coulter, Inc.LTW2025-12-08
15099590799014MicroScanBeckman Coulter, Inc.LTT2025-12-08
15099590799014MicroScanBeckman Coulter, Inc.LTW2025-12-08
15099590799021MicroScanBeckman Coulter, Inc.LTW2025-12-08
15099590799021MicroScanBeckman Coulter, Inc.LTT2025-12-08
15099590799243MicroScanBeckman Coulter, Inc.LON2025-12-08
00860012092109LifeScale ASTAffinity Biosensors, LLCLON2025-10-14
00860012092116LSGNAffinity Biosensors, LLCLON2025-10-14
00860012092123LifeScale SensorAffinity Biosensors, LLCLON2025-10-14
30382904490820NMIC-312BECTON, DICKINSON AND COMPANYLON2025-03-20
30382904490837NMIC/ID-313BECTON, DICKINSON AND COMPANYLON2025-03-20
00850031114029Selux AST Gram Negative PanelSelux Diagnostics, Inc.LTW2024-12-20
00850031114029Selux AST Gram Negative PanelSelux Diagnostics, Inc.LON2024-12-20
00850031114029Selux AST Gram Negative PanelSelux Diagnostics, Inc.LTT2024-12-20
00850031114142Selux Seaparator Reagent KitSelux Diagnostics, Inc.LTT2024-12-20
00850031114142Selux Seaparator Reagent KitSelux Diagnostics, Inc.LON2024-12-20
00850031114142Selux Seaparator Reagent KitSelux Diagnostics, Inc.LTW2024-12-20
00195893563760Selux AST SystemSelux Diagnostics, Inc.LTW2024-12-20
00195893563760Selux AST SystemSelux Diagnostics, Inc.LON2024-12-20
00850031114005Bulk Analyzer Reagent PackSelux Diagnostics, Inc.LTT2024-12-20
00850031114005Bulk Analyzer Reagent PackSelux Diagnostics, Inc.LON2024-12-20
00850031114036AST InoculatorSelux Diagnostics, Inc.LTT2024-12-20