NA

Primary DI
05056080501222
Brand
NA
Company
REMEL EUROPE LIMITED
Model
R30167501
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
GTJAntisera, All Groups, N. Meningitidis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GTJAntisera, All Groups, N. MeningitidisMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K844762000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K844762000MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51Wellcome Diagnostics1985-06-04GTJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056080501222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056080501222050560805012225056080501222

GMDN Terms#

Term, Definition table
TermDefinition
Neisseria meningitidis 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 Neisseria meningitidis 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
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
05056080501567EDTA SolutionREMEL EUROPE LIMITEDGTJ2021-07-21
07350049850221Phadebact CSF TestMkl Diagnostics ABGTJ2016-11-17
05056080500973NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080500980NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080500997NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501130NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501147NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501154NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501161NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501178NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501185NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501192NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501208NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501215NAREMEL EUROPE LIMITEDGTJ2016-09-24
00382902555605BD Directigen™ Neisseria meningitidis Group B and E. coli K1 Test KitBECTON, DICKINSON AND COMPANYGTJ2016-07-07
30382902523506BD Directigen™ Meningitis Test Negative Control ReagentBECTON, DICKINSON AND COMPANYGTJ2016-05-19
00382902523604BD Directigen™ Meningitis Combo Test KitBECTON, DICKINSON AND COMPANYGTJ2016-05-19
00382902524809BD Directigen™ Meningitis Combo Test CardsBECTON, DICKINSON AND COMPANYGTJ2016-05-19
00382902563914BD Directigen™ Specimen Buffer SolutionBECTON, DICKINSON AND COMPANYGTJ2016-05-19
00382902288114BD Difco™ Neisseria Meningitidis Antiserum Group YBECTON, DICKINSON AND COMPANYGTJ2016-05-03
00382902289111BD Difco™ Neisseria Meningitidis Antiserum Group ZBECTON, DICKINSON AND COMPANYGTJ2016-05-03
00382902291015BD Difco™ Neisseria Meningitidis Antiserum Poly 2 Contains Groups X, Y, ZBECTON, DICKINSON AND COMPANYGTJ2016-05-03
00382902225218BD Difco™ Neisseria Meningitidis Antiserum Group ZBECTON, DICKINSON AND COMPANYGTJ2016-04-29
00382902225317BD Difco™ Neisseria Meningitidis Antiserum Group W135BECTON, DICKINSON AND COMPANYGTJ2016-04-29
00382902288015BD Difco™ Neisseria Meningitidis Antiserum Group XBECTON, DICKINSON AND COMPANYGTJ2016-04-29
00382902222811BD Difco™ Neisseria Meningitidis Antiserum Group ABECTON, DICKINSON AND COMPANYGTJ2016-04-28
00382902222910BD Difco™ Neisseria Meningitidis Antiserum Group BBECTON, DICKINSON AND COMPANYGTJ2016-04-28
00382902223016BD Difco™ Neisseria Meningitidis Antiserum Group CBECTON, DICKINSON AND COMPANYGTJ2016-04-28
00382902223115BD Difco™ Neisseria Meningitidis Antiserum Group DBECTON, DICKINSON AND COMPANYGTJ2016-04-28
00382902223214BD Difco™ Neisseria Meningitidis Antiserum Poly Contains Groups A, B, C, DBECTON, DICKINSON AND COMPANYGTJ2016-04-28