FDA.reportPublic FDA data

MICROBACT REAGENT SET D

Primary DI
05032384127917
Brand
MICROBACT REAGENT SET D
Company
OXOID LIMITED
Model
MB1082A
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LQMGram Negative Identification Panel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQMGram Negative Identification PanelMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05032384127917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05032384127917050323841279175032384127917

GMDN Terms#

Term, Definition table
TermDefinition
Multiple bacteria species culture isolate identification control IVD, kitA collection of reagents and other associated materials intended to be used to verify the performance of one or multiple biochemical tests used for the differentiation and/or identification of multiple bacteria species that have been isolated by culture from a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
365355452
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05032384029600ANAEROJAR BASEAG0026A2022-12-12
05032384029044STAPHYTECT PLUSDR0850M2026-01-28
05032384029051STAPHYTECT PLUSDR0850B2026-01-28
05032384550784Thermo Scientific Oxoid Gepotidacin Disc (10 ug) GEP10CT1975B2026-01-21
05032384533121Oxoid Aztreonam/Avibactam Disc (30/20ug) AZA50CT1971B2025-12-12
05032384003914SELENITE CYST.BROTH BASECM0699B2025-07-23
05032384126453PEPTONE WATER (ANDRADE)CM0061B2025-06-27
05032384127993REAGENT SPOT INDOLE DMACAMB1448A2025-06-27
05032384502974IMAGEN Parainfluenza Virus Types 1, 2 and 3K610411-22024-12-30
05032384502981IMAGEN Influenza Virus A and BK610511-22024-12-30
05032384012039AMPICILLIN SELECTIVE SUPP. 1 X 10 VIALSSR0136E2022-12-02
05032384082919ORSAB SELECTIVE SUPPLEMENTSR0195E2024-10-29
05032384083237OXACILLIN RES. SCREENING AGAR BASECM1008B2024-10-29
05032384516018Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test DiscsCT1954B2024-10-28
05032384537723Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test DiCT1960B2024-10-28
05032384128006Microbact Staph 12SMB1561A2024-10-28
05032384128013Microbact Staph Fast Blue ReagentMB1588A2024-10-28
05032384580231Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test DiscsCT1954B2024-10-28
05032384579945Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test DiCT1960B2024-10-28
05700573075706NAK610611-22016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590798987MicroScanBeckman Coulter, Inc.LQM2025-12-08
15099590798994MicroScanBeckman Coulter, Inc.LQM2025-12-08
15099590799007MicroScanBeckman Coulter, Inc.LQM2025-12-08
00848838074325PLATE DRY CLI GRAM+ ID AUTOREMEL, INC.LQM2023-06-20
15099590655402MicroScanBeckman Coulter, Inc.LQM2022-12-05
15099590657239MicroScanBeckman Coulter, Inc.LQM2022-12-05
15099590657321MicroScanBeckman Coulter, Inc.LQM2022-12-05
15099590657604MicroScanBeckman Coulter, Inc.LQM2022-12-05
05032384127955MICROBACT GNB 24E TRAY (40 ID'S)OXOID LIMITEDLQM2022-12-04
05032384127962MICROBACT GNB 12A STRIP (60 ID'S)OXOID LIMITEDLQM2022-12-04
05032384127979MICROBACT GNB 12B STRIP (60 ID'S)OXOID LIMITEDLQM2022-12-04
15099590655181MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655198MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655204MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655211MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655228MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655235MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655242MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655259MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655495MicroscanBeckman Coulter, Inc.LQM2022-11-15
15099590655686MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655709MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655808MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655822MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655846MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655853MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655860MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655884MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590765361MicroScanBeckman Coulter, Inc.LQM2022-08-01
15099590765378MicroScanBeckman Coulter, Inc.LQM2022-08-01