FDA.reportPublic FDA data

MICROBACT GNB 12A STRIP (60 ID'S)

Primary DI
05032384127962
Brand
MICROBACT GNB 12A STRIP (60 ID'S)
Company
OXOID LIMITED
Model
MB1132A
Published
2022-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
05032384127962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05032384127962050323841279625032384127962

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05032384082919ORSAB SELECTIVE SUPPLEMENTSR0195E2024-10-29
05032384083237OXACILLIN RES. SCREENING AGAR BASECM1008B2024-10-29
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
05032384526123Oxoid Lefamulin (20ug) LMU20 Antimicrobial Susceptibility Test DiscsCT1951B2024-10-01
05032384002092Desoxycholate Citrate Agar (Hynes)CM0227B2024-08-13
05032384011414Campylobacter Selective Supplement (Skirrow)SR0069H2024-08-13
05032384028467Oxoid™ (8 Places, 90 mm skirt) Antimicrobial Susceptibility Disc DispenserST80902024-08-13
05032384139811XLT-4 Selective SupplementSR0237C2024-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848838074325PLATE DRY CLI GRAM+ ID AUTOREMEL, INC.LQM2023-06-20
05032384127917MICROBACT REAGENT SET DOXOID LIMITEDLQM2022-12-07
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
05032384127979MICROBACT GNB 12B STRIP (60 ID'S)OXOID LIMITEDLQM2022-12-04
15099590655181MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655198MicroScanBeckman Coulter, Inc.LQM2022-11-15
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15099590655884MicroScanBeckman Coulter, Inc.LQM2022-11-15
03573026131913VITEK® 2 GNBIOMERIEUX , INC.LQM2020-06-02
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15099590733919MicroScanBeckman Coulter, Inc.LQM2019-12-18
00382904480073BD Phoenix™ NIDBECTON, DICKINSON AND COMPANYLQM2018-05-25
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