FDA.reportPublic FDA data

GSD Brucella IgG ELISA

Primary DI
B350GSD0130070
Brand
GSD Brucella IgG ELISA
Company
Gold Standard Diagnostics Corporation
Model
GSD01-3007
Catalog number
GSD01-3007
Device description
Brucella IgG ELISA Test Kit
Published
2017-07-12
Public version status
Update
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
GSMAntisera, Fluorescent, Brucella Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GSMAntisera, Fluorescent, Brucella Spp.Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B350GSD0130070PrimaryHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
790524891
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B350GSD0130090Influenza A IgG ELISA Test KitGSD01-3009GSD01-30092022-12-07
B350GSD0130100Influenza B IgG ELISA Test KitGSD01-3010GSD01-30102022-10-07
B3507207900Gold Standard Diagnostics Is-ANA Screen ELISA Test Kit720-790720-7902025-02-26
B350GSD0113000Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test KitGSD01-13002016-09-27
B350GSD0116005C0Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5CGSD01-1600-5CGSD01-1600-5C2024-12-06
B350GSD051600MW0Microtiterplates (5)GSD05-1600-MWGSD05-1600-MW2024-10-22
B35000400R0AIX1000 Analyzer00400R00400R2023-10-31
B350GSD011600DYE0AIX1000 Performance Check Dye KitGSD01-1600-DYEGSD01-1600-DYE2023-09-13
B350GSD051600NC0RPR Non-Reactive ControlGSD05-1600-NCGSD05-1600-NC2023-09-13
B350GSD051600PC0RPR Reactive ControlGSD05-1600-PCGSD05-1600-PC2023-09-13
B350GSD1600WCASE0MicrotiterplatesGSD-1600-W-CASEGSD-1600-W-CASE2022-10-14
B350004000AIX1000 Analyzer004002016-11-29
B350GSD0116000Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test SystemGSD01-16002016-09-27
B350GSD341600R0Gold Standard Diagnostics RPR Reagent PackGSD34-1600-RGSD34-1600-R2016-11-29
B350GSD011600DIL0GSD RPR DiluentGSD01-1600-DILGSD01-1600-DIL2025-10-16
B350GSD0110010Gold Standard Diagnostics H. pylori ELISA IgA Test KitGSD01-10012016-09-27
B350GSD051600W0GSD RPR Microtiterplate - 5 pack sleeveGSD05-1600-WGSD05-1600-W2022-11-25
B350GSD011029CP0SARS-CoV-2 Component PackGSD01-1029-CPGSD01-1029-CP2022-10-07
B350GSD011029SP0SARS-CoV-2 IgA Sera PackGSD01-1029-SPGSD01-1029-SP2022-10-07
B350GSD011002RP0IgM Reagent PackGSD01-1002-RPGSD01-1002-RP2022-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ENTIBRUG00500NovaLisa Brucella IgGGold Standard Diagnostics Frankfurt GmbHGSM2024-08-26
06974621793235LT Brucella Antisera Test ReagentsZhuhai Longtime Biological Technology Co., LtdGSM2023-08-01
06974621793242LT Brucella Antisera Test ReagentsZhuhai Longtime Biological Technology Co., LtdGSM2023-08-01
04049016027553Anti-Brucella abortus ELISA (IgA)EUROIMMUN Medizinische Labordiagnostika AGGSM2016-09-24
04049016027560Anti-Brucella abortus ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGSM2016-09-24
04049016027577Anti-Brucella abortus ELISA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGSM2016-09-24
00695684011000BRUCELLA ABORTUS ANTISERUMGERMAINE LABORATORIES, INCGSM2016-04-12