FDA.reportPublic FDA data

LSGN

Primary DI
00860012092116
Brand
LSGN
Company
Affinity Biosensors, LLC
Model
LS6503
Device description
LifeScale Gram Negative Kit (LSGN) is used with the LifeScale AST system for testing positive blood culture samples containing gram-negative bacilli.
Published
2025-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K211815000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211815000LifeScale Gram Negative Kit (LSGN) with the LifeScale AST SystemAffinity Biosensors2024-04-02SAN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012092116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012092116008600120921168600120921160860012092116

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.

Contacts#

Phone, Email table
PhoneEmail
805-960-5100info@affinitybio.com

Regulatory Flags#

DUNS number
802576830
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
00860012092109LifeScale AST3010-00002025-10-14
00860012092123LifeScale SensorLS65012025-10-14

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
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
10850031114149Selux Seaparator Reagent KitSelux Diagnostics, Inc.LON2024-12-20
00850031114135Selux AST Gram Positive PanelsSelux Diagnostics, Inc.LON2024-12-17