FDA.reportPublic FDA data

VITEK® REVEAL™ BC GN02-AST

Primary DI
03573026638887
Brand
VITEK® REVEAL™ BC GN02-AST
Company
BIOMERIEUX , INC.
Model
VITEK® REVEAL™ BC GN02-AST
Device description
VITEK REVEAL BC GN02-AST is an antibiotic panel (20 panels/box)
Published
2024-10-09
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
SANAutomated antimicrobial susceptibility test system for positive blood culture samples

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SANAutomated Antimicrobial Susceptibility Test System For Positive Blood Culture SamplesMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230675000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230675000VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSpecific Diagnostics, LLC2024-06-20SAN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026638887PrimaryGS10
03573026638894Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026638887035730266388873573026638887
03573026638894035730266388943573026638894

GMDN Terms#

Term, Definition table
TermDefinition
Antibacterial susceptibility testing disc IVDA susceptibility testing disc impregnated with a defined amount of a specific an antibacterial, also known as an antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection) intended to be used to determine the susceptibility of a specific bacterial organism (excluding mycobacteria) isolated from a clinical specimen by culture, using a disc diffusion method.

Storage And Handling#

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

Regulatory Flags#

DUNS number
086785110
Device count
20
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
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
07350136800344ASTar BC G- Kit softwareQ-Linea ABSAN2026-05-12
00860012092109LifeScale ASTAffinity Biosensors, LLCSAN2025-10-14
00860012092116LSGNAffinity Biosensors, LLCSAN2025-10-14
00860012092123LifeScale SensorAffinity Biosensors, LLCSAN2025-10-14
00860007326929VITEK® REVEAL™ SENSOR PANELBIOMERIEUX , INC.SAN2024-10-09
00860007326905VITEK® REVEAL™BIOMERIEUX , INC.SAN2024-10-09
00860007326912VITEK® REVEAL™ SEALERBIOMERIEUX , INC.SAN2024-10-09
03573026638900VITEK® REVEAL™ SENSOR PANELBIOMERIEUX , INC.SAN2024-10-09
03573026638894VITEK® REVEAL™ BC GN02-ASTSpecific Diagnostics, Inc.SAN2024-10-09
07350136800047ASTar InstrumentQ-Linea ABSAN2024-09-30
07350136800054ASTar BC G- Kit softwareQ-Linea ABSAN2024-09-30
07350136800061ASTar BC G- Consumable kit Q-Linea ABSAN2024-09-30
07350136800078ASTar BC G- Frozen insert Q-Linea ABSAN2024-09-30