FDA.reportPublic FDA data

VITEK® 2 AST-YS09

Primary DI
03573026619350
Brand
VITEK® 2 AST-YS09
Company
BIOMERIEUX , INC.
Model
VITEK® 2 AST-YS09
Device description
The VITEK 2 ® Yeast Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant yeast.
Published
2019-04-05
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
NGZSUSCEPTIBILITY TEST PLATE, ANTIFUNGAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGZSusceptibility Test Plate, AntifungalMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092454000
K133817000
K133952000
K151817000
K151923000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092454000VITEK 2 YEAST VORICONAZOLEbioMerieux, Inc.2010-05-21NGZ
K133817000VITEK 2 AST - YEAST FLUCONAZOLEbioMerieux, Inc.2014-08-05NGZ
K133952000VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINEbioMerieux, Inc.2014-08-19NGZ
K151817000VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mLbioMerieux, Inc.2016-02-18NGZ
K151923000VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)bioMerieux, Inc.2016-03-25NGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026619268PackageGS120In Commercial Distribution
03573026619350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026619268035730266192683573026619268
03573026619350035730266193503573026619350

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
05032384571413SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-25
05032384571451SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-25
05032384503513SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-25
05032384474561SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-25
05032384571611SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-24
05032384571789SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-24
05032384571321SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-24
05032384511419SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-24
00848838036835SENSITITRE YEASTONE SUSCEPTIBILITY PLATESREMEL, INC.NGZ2023-06-20
03573026623838ETEST® Fluconazole (FL)BIOMERIEUX SANGZ2021-12-03
03573026623562ETEST®BIOMERIEUX SANGZ2021-12-03
03573026550363ETEST® Itraconazole (IT)BIOMERIEUX SANGZ2019-10-22
03573026616014Etest® ITRACONAZOLEBIOMERIEUX SANGZ2019-10-22
03573026619268VITEK 2 ® AST-YS09BIOMERIEUX , INC.NGZ2019-04-05
03573026529758VITEK® 2 AST-YS05BIOMERIEUX , INC.NGZ2017-01-09
03573026373047VITEK® 2 AST-YS05BIOMERIEUX , INC.NGZ2017-01-09
03573026550158ETEST® Fluconazole (FL)BIOMERIEUX SANGZ2016-12-12
03573026550165ETEST® Flucytosine (FC)BIOMERIEUX SANGZ2016-12-12
03573026550516ETEST® Voriconazole (VO)BIOMERIEUX SANGZ2016-12-12
03573026377731ETEST® Flucytosine (FC)BIOMERIEUX SANGZ2016-12-12
03573026377717Etest® FLUCONAZOLEBIOMERIEUX SANGZ2016-12-12
03573026378974Etest® VORICONAZOLEBIOMERIEUX SANGZ2016-12-12
03573026548889Etest® FLUCONAZOLEBIOMERIEUX SANGZ2016-11-18
03573026548896ETEST® Flucytosine (FC)BIOMERIEUX SANGZ2016-11-18
03573026549091Etest® ITRACONAZOLEBIOMERIEUX SANGZ2016-11-18
03573026253318Etest® ITRACONAZOLEBIOMERIEUX SANGZ2016-11-18
03573026252885Etest® FLUCYTOSINEBIOMERIEUX SANGZ2016-11-18
M578YO2IVD2SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2016-09-24
M578YO3IVD2SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2016-09-24
00848838018817NAREMEL, INC.NGZ2016-09-24