FDA.reportPublic FDA data

NA

Primary DI
05056080501062
Brand
NA
Company
REMEL EUROPE LIMITED
Model
R30165401
Published
2016-09-24
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
GSNAntiserum, Positive And Negative Febrile Antigen Control Serum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GSNAntiserum, Positive And Negative Febrile Antigen Control SerumMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056080501062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056080501062050560805010625056080501062

GMDN Terms#

Term, Definition table
TermDefinition
Salmonella paratyphi 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 Salmonella paratyphi bacteria in 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
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
00816387020520IMMYImmuno-Mycologics, Inc.GSN2023-12-11
05056080501055NAREMEL EUROPE LIMITEDGSN2016-09-24
00695684016012FEBRILE NEGATIVE CONTROLGERMAINE LABORATORIES, INCGSN2016-04-27
00695684016005FEBRILE POSITIVE CONTROLGERMAINE LABORATORIES, INCGSN2016-04-21
00695684016067SALMONELLA H POLY POSITIVE CONTROLGERMAINE LABORATORIES, INCGSN2016-04-21
00695684016111SALMONELLA O POLY POSITIVE CONTROLGERMAINE LABORATORIES, INCGSN2016-04-21