FDA.reportPublic FDA data

BRUCELLA ABORTUS ANTISERUM

Primary DI
00695684011000
Brand
BRUCELLA ABORTUS ANTISERUM
Company
GERMAINE LABORATORIES, INC
Model
1100
Device description
Brucella Abortus Antiserum is intended for use as control material for Brucella antigens.
Published
2016-04-12
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
00695684011000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00695684011000006956840110006956840110000695684011000

GMDN Terms#

Term, Definition table
TermDefinition
Multiple febrile infection-associated bacteria antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple bacteria associated with febrile infection in a clinical specimen. Bacteria detected may include Brucella, Salmonella and/or Rickettsia.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176458115
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
00695684744250AimStep Flu A&B Test Kit744252026-05-11
00695684773014AimStrip Tandem Lipid Profile and glucose measuring systemILM-0001A2020-03-13
00695684775506AimStrip Tandem blood glucose test stripsILM-0001A2020-03-13
00695684773106AimStrip Tandem Total Cholesterol Test StripsILM-0001A2020-03-13
00695684773120AimStrip Tandem Total Cholesterol Control SolutionILM-0001A2020-03-13
00695684774103AimStrip Tandem Total Triglycerides Test StripsILM-0001A2020-03-13
00695684774127AimStrip Tandem Total Triglycerides Control SolutionILM-0001A2020-03-13
00695684775124AimStrip Tandem Glucose control solutionILM-0001A2020-03-13
00695684423384AimScreen Fentanyl423382024-04-01
10695684423381AimScreen Fentanyl423382024-04-01
00695684893019Pregcolor Plus893012023-08-09
00695684971014Pregcolor Premium 97101PCP2023-08-09
00695684957018Mosie Baby Pregnancy Test957012019-10-21
00695684885304AIMSTRIP PREGNANCY885302016-04-11
00695684888305AIMSTRIP COMBO PREGNANCY888302016-04-27
00695684891015AccuHome Pregnancy Test891012016-04-11
00695684891022AccuHome Pregnancy Test891022016-04-11
00695684891404AccuHome Pregnancy Test891402016-04-11
00695684970253AIMSTEP PREGNANCY970252016-04-11
00695684970307AIMSTEP PREGNANCY970302016-04-11

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
B350GSD0130070GSD Brucella IgG ELISAGold Standard Diagnostics CorporationGSM2017-07-12
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