FDA.reportPublic FDA data

NA

Primary DI
05056080500164
Brand
NA
Company
REMEL EUROPE LIMITED
Model
R30855501
Published
2016-12-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
05056080500164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056080500164050560805001645056080500164

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Brucella species total antibody IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to multiple species of Brucella bacteria in a clinical specimen, using an agglutination method. It is commonly used for the detection of infection with or exposure to Bordetella bacteria which may include B. abortus and B. melitensis.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401322295600ITechnicalSupport@remel.com

Regulatory Flags#

DUNS number
232600853
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
05056080500928Shigella boydii polyvalent 1 (1-6) Agglutinating SerumR301639012026-05-05
05056080501024NAR301650012016-12-09
05056080501888Wellcolex E.coli O157R309595012021-07-21
05056080501598Proteus OX2 Agglutinating SerumR301657012021-07-21
05056080500065NAR308550012016-09-24
05056080500126NAR308553012016-09-24
05056080500317NAR309577012016-09-24
05056080500324NAR309578012016-09-24
05056080500331NAR309579012016-09-24
05056080500348NAR309580012016-09-24
05056080500379NAR309583012016-09-24
05056080500409NAR309586012016-09-24
05056080500591NAR301606012016-09-24
05056080500607NAR301607012016-09-24
05056080500614NAR301608012016-09-24
05056080500638NAR301610012016-09-24
05056080500645NAR301611012016-09-24
05056080500652NAR301612012016-09-24
05056080500713NAR301618012016-09-24
05056080500768NAR301623012016-09-24

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
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
00695684010003BRUCELLA ABORTUS ANTIGENGERMAINE LABORATORIES, INCGSO2016-04-12