FDA.reportPublic FDA data

Vibrio cholerae Inaba Agglutinating Sera

Primary DI
05056080501031
Brand
Vibrio cholerae Inaba Agglutinating Sera
Company
REMEL EUROPE LIMITED
Model
R30165101
Published
2021-07-21
Public version status
New
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.

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056080501031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056080501031050560805010315056080501031

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
+4401256694238microbiology.techsupport.uk@thermofisher.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
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
00695684010003BRUCELLA ABORTUS ANTIGENGERMAINE LABORATORIES, INCGSO2016-04-12