NA

Primary DI
05056080501086
Brand
NA
Company
REMEL EUROPE LIMITED
Model
R30166101
Published
2016-09-24
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
GRPAntisera, All Types, H. Influenza

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GRPAntisera, All Types, H. InfluenzaMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056080501086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056080501086050560805010865056080501086

GMDN Terms#

Term, Definition table
TermDefinition
Haemophilus influenzae culture isolate 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 strains of Haemophilus influenzae 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
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
15060392377601Mast Assure AntiseraMAST GROUP LIMITEDGRP2022-04-06
15060392376338Mast Assure AntiseraMAST GROUP LIMITEDGRP2021-09-22
04048474025309Haemophilus influenza B IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGRP2019-06-06
00404847425307Haemophilus influenza B IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGRP2019-06-06
15060392377564Mast Assure AntiseraMAST GROUP LIMITEDGRP2018-12-12
15060392377571Mast Assure AntiseraMAST GROUP LIMITEDGRP2018-08-17
07350049850115Phadebact Haemophilus TestMkl Diagnostics ABGRP2016-11-17
05051700006767VaccZyme™ Human Anti-Haemophilus Influenzae type b Enzyme Immunoassay KitTHE BINDING SITE GROUP LIMITEDGRP2016-09-24
05056080501079NAREMEL EUROPE LIMITEDGRP2016-09-24
05056080501093NAREMEL EUROPE LIMITEDGRP2016-09-24
05056080501109NAREMEL EUROPE LIMITEDGRP2016-09-24
05056080501116NAREMEL EUROPE LIMITEDGRP2016-09-24
05056080501123NAREMEL EUROPE LIMITEDGRP2016-09-24
05713106034620H. influenzae Type b serum, 1 mLSsi Diagnostica A/SGRP2016-09-13
05713106852057ImmuLex H. influenzae type b antiserum, 1,5 mLSsi Diagnostica A/SGRP2016-09-13
05713106914601ImmuLex H. influenzae type a antiserum, 1,5 mLSsi Diagnostica A/SGRP2016-09-13
05713106914618ImmuLex H. influenzae type c antiserum, 1,5 mLSsi Diagnostica A/SGRP2016-09-13
05713106914625ImmuLex H. influenzae type d antiserum, 1,5mLSsi Diagnostica A/SGRP2016-09-13
05713106914649ImmuLex H. influenzae type e antiserum, 1,5mLSsi Diagnostica A/SGRP2016-09-13
05713106914656ImmuLex H. influenzae type f antiserum, 1,5mLSsi Diagnostica A/SGRP2016-09-13
05713106914670ImmuLex H. influenzae polyv. Antiserum, 1,5mLSsi Diagnostica A/SGRP2016-09-13
00382902223719BD Difco™ Haemophilus influenzae Antiserum Poly Contains Types a, b, c, d, e, fBECTON, DICKINSON AND COMPANYGRP2016-07-07
00382902522607BD Directigen™ H. influenzae type b Test KitBECTON, DICKINSON AND COMPANYGRP2016-05-19
00382902278917BD Difco™ Haemophilus influenzae Antiserum Type cBECTON, DICKINSON AND COMPANYGRP2016-04-29
00382902279013BD Difco™ Haemophilus influenzae Antiserum Type dBECTON, DICKINSON AND COMPANYGRP2016-04-29
00382902279112BD Difco™ Haemophilus Influenzae Antiserum Type eBECTON, DICKINSON AND COMPANYGRP2016-04-29
00382902279211BD Difco™ Haemophilus Influenzae Antiserum Type fBECTON, DICKINSON AND COMPANYGRP2016-04-29
00382902223610BD Difco™ Haemophilus Influenzae Antiserum Type bBECTON, DICKINSON AND COMPANYGRP2016-04-28
00382902225010BD Difco™ Haemophilus Influenzae Antiserum Type aBECTON, DICKINSON AND COMPANYGRP2016-04-28