FDA.reportPublic FDA data

ASTar BC G- Frozen insert

Primary DI
07350136800078
Brand
ASTar BC G- Frozen insert
Company
Q-Linea AB
Model
50006671
Device description
Antimicrobial Susceptibility Testing - Gram negative
Published
2024-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
SANAutomated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short IncubationMicrobiology2
SANAutomated Antimicrobial Susceptibility Test System For Positive Blood Culture SamplesMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221688000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221688000ASTar BC G- Kit and ASTar InstrumentQ-Linea AB2024-04-26SAN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350136800078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350136800078073501368000787350136800078

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type pathogen antimicrobial susceptibility testing kit IVDA collection of reagents and other associated materials containing a range of antimicrobial agents e.g., (antibacterial/antibiotic, antifungal/antimycotic and/or antimycobacterial) that may be impregnated on individual testing discs, in a strip format or a microplate, intended to be used to determine the susceptibility profile of a specific pathogen (bacterium, fungus and/or Mycobacterium), in a clinical specimen and/or culture isolate.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius-15 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 5703168943support@qlinea.com
+4618235000order@qlinea.com

Regulatory Flags#

DUNS number
775813863
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350136800344ASTar BC G- Kit software50005827 version 22026-05-12
07350136800054ASTar BC G- Kit software500058272024-09-30
07350136800047ASTar Instrument500031352024-09-30
07350136800061ASTar BC G- Consumable kit 500064342024-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350136800344ASTar BC G- Kit softwareQ-Linea ABLON2026-05-12
07350136800344ASTar BC G- Kit softwareQ-Linea ABSAN2026-05-12
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
03573026647780VITEK® 2 AST-N816BIOMERIEUX , INC.LON2025-11-21
00860012092109LifeScale ASTAffinity Biosensors, LLCSAN2025-10-14
00860012092109LifeScale ASTAffinity Biosensors, LLCLON2025-10-14
00860012092116LSGNAffinity Biosensors, LLCLON2025-10-14
00860012092116LSGNAffinity Biosensors, LLCSAN2025-10-14
00860012092123LifeScale SensorAffinity Biosensors, LLCLON2025-10-14
00860012092123LifeScale SensorAffinity Biosensors, LLCSAN2025-10-14
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