FDA.reportPublic FDA data

NA

Primary DI
05056080501024
Brand
NA
Company
REMEL EUROPE LIMITED
Model
R30165001
Published
2016-12-09
Public version status
Update
Distribution status
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.
GSQAntiserum, Vibrio Cholerae, All Varieties

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GSOAntigens (Febrile), Agglutination, Brucella Spp.Microbiology2
GSQAntiserum, Vibrio Cholerae, All VarietiesMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056080501024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056080501024050560805010245056080501024

GMDN Terms#

Term, Definition table
TermDefinition
Vibrio cholerae culture isolate antigen (multiple serotype) IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Vibrio cholerae bacteria isolated by culture from a clinical specimen, using an agglutination method.

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
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
05056080500867NAR301633012016-09-24

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
15060392376512Mast Assure AntiseraMAST GROUP LIMITEDGSQ2021-04-09
04048474034554Brucella IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGSO2019-06-10
00404847434552Brucella IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGSO2019-06-10
15060392379254Mast Assure AntiseraMAST GROUP LIMITEDGSQ2018-08-23
15060392376529Mast AssureMAST GROUP LIMITEDGSQ2018-07-25
15060392376505Mast AssureMAST GROUP LIMITEDGSQ2018-05-02
15060392376536Mast AssureMAST GROUP LIMITEDGSQ2018-05-02
00816576026715NAHARDY DIAGNOSTICSGSQ2017-10-12
00816576023073NAHARDY DIAGNOSTICSGSQ2017-03-28
05056080500164NAREMEL EUROPE LIMITEDGSO2016-12-09
05056080500171NAREMEL EUROPE LIMITEDGSO2016-12-09
05056080501017NAREMEL EUROPE LIMITEDGSO2016-12-09
05056080501048NAREMEL EUROPE LIMITEDGSO2016-12-09
05056080501000NAREMEL EUROPE LIMITEDGSO2016-10-24
00816576022113NAHARDY DIAGNOSTICSGSQ2016-09-17
00816576022267NAHARDY DIAGNOSTICSGSQ2016-09-17
00816576022335NAHARDY DIAGNOSTICSGSQ2016-09-17
00382902243014BD Difco™ Vibrio Cholerae Antiserum InabaBECTON, DICKINSON AND COMPANYGSQ2016-04-29
00382902243113BD Difco™ Vibrio Cholerae Antiserum OgawaBECTON, DICKINSON AND COMPANYGSQ2016-04-29
00382902243212BD Difco™ Vibrio cholerae Antiserum Poly Hikojima, Inaba, OgawaBECTON, DICKINSON AND COMPANYGSQ2016-04-29
00695684010027BRUCELLA MELITENSIS ANTIGENGERMAINE LABORATORIES, INCGSO2016-04-21
00695684010003BRUCELLA ABORTUS ANTIGENGERMAINE LABORATORIES, INCGSO2016-04-12