FDA.reportPublic FDA data

VITEK® REVEAL™ BC GN02-AST

Primary DI
03573026638894
Brand
VITEK® REVEAL™ BC GN02-AST
Company
Specific Diagnostics, 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
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
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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078520283
Device count
20
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 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
03573026638887VITEK® REVEAL™ BC GN02-ASTBIOMERIEUX , 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
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