FDA.reportPublic FDA data

Selux AST Gram Positive Panels

Primary DI
00850031114135
Brand
Selux AST Gram Positive Panels
Company
Selux Diagnostics, Inc.
Model
01-80002
Published
2024-12-17
Public version status
New
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
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
LTTPanels, Test, Susceptibility, Antimicrobial
LTWSusceptibility Test Cards, Antimicrobial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short IncubationMicrobiology2
LTTPanels, Test, Susceptibility, AntimicrobialMicrobiology2
LTWSusceptibility Test Cards, AntimicrobialMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211759000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211759000Selux AST System; Model AST Gen 1.0Selux Diagnostics, Inc.2023-01-18LON

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850031114132PackageGS120In Commercial Distribution
00850031114135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003111413210850031114132
00850031114135008500311141358500311141350850031114135

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial susceptibility analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the in vitro determination of an antimicrobial susceptibility profile by monitoring the growth rate of a microbiological organism from a clinical specimen and/or culture isolate when exposed to a range ofantimicrobials. Growth detection technology used may include immunoassay, colorimetry, chromatography, photometric and/or carbon dioxide production.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079715313
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850031114029Selux AST Gram Negative Panel01-800012024-12-20
00850031114142Selux Seaparator Reagent Kit2802202024-12-20
00195893563760Selux AST System01-10014, 2800212024-12-20
00850031114005Bulk Analyzer Reagent Pack01-100192024-12-20
10850031114026Selux AST Gram Negative Panel01-800012024-12-20
00850031114036AST Inoculator2800212024-12-20
00850031114043AST Analyzer01-100142024-12-20
00850031114067PBC Separator with Selux AST System02-100012024-12-20
10850031114149Selux Seaparator Reagent Kit2802202024-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30382904490851NMIC-315BECTON, DICKINSON AND COMPANYLON2026-01-29
15099590798970MicroScanBeckman Coulter, Inc.LTW2025-12-08
15099590798970MicroScanBeckman Coulter, Inc.LTT2025-12-08
15099590798987MicroScanBeckman Coulter, Inc.LTT2025-12-08
15099590798987MicroScanBeckman Coulter, Inc.LTW2025-12-08
15099590798994MicroScanBeckman Coulter, Inc.LTT2025-12-08
15099590798994MicroScanBeckman Coulter, Inc.LTW2025-12-08
15099590799007MicroScanBeckman Coulter, Inc.LTW2025-12-08
15099590799007MicroScanBeckman Coulter, Inc.LTT2025-12-08
15099590799014MicroScanBeckman Coulter, Inc.LTT2025-12-08
15099590799014MicroScanBeckman Coulter, Inc.LTW2025-12-08
15099590799021MicroScanBeckman Coulter, Inc.LTW2025-12-08
15099590799021MicroScanBeckman Coulter, Inc.LTT2025-12-08
00860012092109LifeScale ASTAffinity Biosensors, LLCLON2025-10-14
00860012092116LSGNAffinity Biosensors, LLCLON2025-10-14
00860012092123LifeScale SensorAffinity Biosensors, LLCLON2025-10-14
30382904490820NMIC-312BECTON, DICKINSON AND COMPANYLON2025-03-20
30382904490837NMIC/ID-313BECTON, DICKINSON AND COMPANYLON2025-03-20
00850031114029Selux AST Gram Negative PanelSelux Diagnostics, Inc.LON2024-12-20
00850031114029Selux AST Gram Negative PanelSelux Diagnostics, Inc.LTT2024-12-20
00850031114029Selux AST Gram Negative PanelSelux Diagnostics, Inc.LTW2024-12-20
00850031114142Selux Seaparator Reagent KitSelux Diagnostics, Inc.LTT2024-12-20
00850031114142Selux Seaparator Reagent KitSelux Diagnostics, Inc.LTW2024-12-20
00850031114142Selux Seaparator Reagent KitSelux Diagnostics, Inc.LON2024-12-20
00195893563760Selux AST SystemSelux Diagnostics, Inc.LON2024-12-20
00195893563760Selux AST SystemSelux Diagnostics, Inc.LTW2024-12-20
00850031114005Bulk Analyzer Reagent PackSelux Diagnostics, Inc.LON2024-12-20
00850031114005Bulk Analyzer Reagent PackSelux Diagnostics, Inc.LTT2024-12-20
00850031114036AST InoculatorSelux Diagnostics, Inc.LTT2024-12-20
00850031114036AST InoculatorSelux Diagnostics, Inc.LTW2024-12-20