FDA.reportPublic FDA data

Selux Seaparator Reagent Kit

Primary DI
00850031114142
Brand
Selux Seaparator Reagent Kit
Company
Selux Diagnostics, Inc.
Model
280220
Published
2024-12-20
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
QZXPositive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short IncubationMicrobiology2
LTTPanels, Test, Susceptibility, AntimicrobialMicrobiology2
LTWSusceptibility Test Cards, AntimicrobialMicrobiology2
QZXPositive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility TestingMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223493000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223493000PBC Separator with Selux AST SystemSelux Diagnostics, Inc.2024-02-15QZX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850031114149PackageGS110In Commercial Distribution
20850031114146PackageGS16In Commercial Distribution
00850031114142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003111414910850031114149
2085003111414620850031114146
00850031114142008500311141428500311141420850031114142

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.

Regulatory Flags#

DUNS number
079715313
Device count
1
Lot or batch
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
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
00850031114135Selux AST Gram Positive Panels01-800022024-12-17

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
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
00850031114043AST AnalyzerSelux Diagnostics, Inc.LTW2024-12-20
00850031114043AST AnalyzerSelux Diagnostics, Inc.LTT2024-12-20
00850031114067PBC Separator with Selux AST SystemSelux Diagnostics, Inc.QZX2024-12-20