FDA.reportPublic FDA data

BRUCELLA ABORTUS ANTIGEN

Primary DI
00695684010003
Brand
BRUCELLA ABORTUS ANTIGEN
Company
GERMAINE LABORATORIES, INC
Model
1000
Device description
Brucella Abortus Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection.
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
GSOAntigens (Febrile), Agglutination, Brucella Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GSOAntigens (Febrile), Agglutination, Brucella Spp.Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00695684010003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00695684010003006956840100036956840100030695684010003

GMDN Terms#

Term, Definition table
TermDefinition
Multiple febrile infection-associated bacteria antigen IVD, kit, agglutinationA collection of reagents and other associated materials 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, using an agglutination method. 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
00840239034557Brucella IgG ELISADRG International IncGSO2023-08-24
05056080501031Vibrio cholerae Inaba Agglutinating SeraREMEL EUROPE LIMITEDGSO2021-07-21
04048474034554Brucella IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGSO2019-06-10
00404847434552Brucella IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGSO2019-06-10
05056080500164NAREMEL EUROPE LIMITEDGSO2016-12-09
05056080500171NAREMEL EUROPE LIMITEDGSO2016-12-09
05056080501017NAREMEL EUROPE LIMITEDGSO2016-12-09
05056080501024NAREMEL EUROPE LIMITEDGSO2016-12-09
05056080501048NAREMEL EUROPE LIMITEDGSO2016-12-09
05056080501000NAREMEL EUROPE LIMITEDGSO2016-10-24
00695684010027BRUCELLA MELITENSIS ANTIGENGERMAINE LABORATORIES, INCGSO2016-04-21