Home GUDID 05056080501567 EDTA Solution
Primary DI 05056080501567
Brand EDTA Solution
Company REMEL EUROPE LIMITED
Model R30164501
Published 2021-07-21
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name GTJ Antisera, All Groups, N. Meningitidis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GTJ Antisera, All Groups, N. Meningitidis Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05056080501567 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05056080501567 05056080501567 5056080501567
GMDN Terms# Term, Definition table Term Definition Multiple meningitis-associated bacteria antigen IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from one or multiple bacteria associated with meningitis, in a clinical specimen. Bacteria detected may include Haemophilus influenzae, Streptococcus pneumoniae, Neisseria meningitidis, Group B streptococcus or Escherichia coli (E. coli) bacteria.
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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07350049850221 Phadebact CSF Test Mkl Diagnostics AB GTJ 2016-11-17 05056080500973 NA REMEL EUROPE LIMITED GTJ 2016-09-24 05056080500980 NA REMEL EUROPE LIMITED GTJ 2016-09-24 05056080500997 NA REMEL EUROPE LIMITED GTJ 2016-09-24 05056080501130 NA REMEL EUROPE LIMITED GTJ 2016-09-24 05056080501147 NA REMEL EUROPE LIMITED GTJ 2016-09-24 05056080501154 NA REMEL EUROPE LIMITED GTJ 2016-09-24 05056080501161 NA REMEL EUROPE LIMITED GTJ 2016-09-24 05056080501178 NA REMEL EUROPE LIMITED GTJ 2016-09-24 05056080501185 NA REMEL EUROPE LIMITED GTJ 2016-09-24 05056080501192 NA REMEL EUROPE LIMITED GTJ 2016-09-24 05056080501208 NA REMEL EUROPE LIMITED GTJ 2016-09-24 05056080501215 NA REMEL EUROPE LIMITED GTJ 2016-09-24 05056080501222 NA REMEL EUROPE LIMITED GTJ 2016-09-24 00382902555605 BD Directigen™ Neisseria meningitidis Group B and E. coli K1 Test Kit BECTON, DICKINSON AND COMPANY GTJ 2016-07-07 30382902523506 BD Directigen™ Meningitis Test Negative Control Reagent BECTON, DICKINSON AND COMPANY GTJ 2016-05-19 00382902523604 BD Directigen™ Meningitis Combo Test Kit BECTON, DICKINSON AND COMPANY GTJ 2016-05-19 00382902524809 BD Directigen™ Meningitis Combo Test Cards BECTON, DICKINSON AND COMPANY GTJ 2016-05-19 00382902563914 BD Directigen™ Specimen Buffer Solution BECTON, DICKINSON AND COMPANY GTJ 2016-05-19 00382902288114 BD Difco™ Neisseria Meningitidis Antiserum Group Y BECTON, DICKINSON AND COMPANY GTJ 2016-05-03 00382902289111 BD Difco™ Neisseria Meningitidis Antiserum Group Z BECTON, DICKINSON AND COMPANY GTJ 2016-05-03 00382902291015 BD Difco™ Neisseria Meningitidis Antiserum Poly 2 Contains Groups X, Y, Z BECTON, DICKINSON AND COMPANY GTJ 2016-05-03 00382902225218 BD Difco™ Neisseria Meningitidis Antiserum Group Z BECTON, DICKINSON AND COMPANY GTJ 2016-04-29 00382902225317 BD Difco™ Neisseria Meningitidis Antiserum Group W135 BECTON, DICKINSON AND COMPANY GTJ 2016-04-29 00382902288015 BD Difco™ Neisseria Meningitidis Antiserum Group X BECTON, DICKINSON AND COMPANY GTJ 2016-04-29 00382902222811 BD Difco™ Neisseria Meningitidis Antiserum Group A BECTON, DICKINSON AND COMPANY GTJ 2016-04-28 00382902222910 BD Difco™ Neisseria Meningitidis Antiserum Group B BECTON, DICKINSON AND COMPANY GTJ 2016-04-28 00382902223016 BD Difco™ Neisseria Meningitidis Antiserum Group C BECTON, DICKINSON AND COMPANY GTJ 2016-04-28 00382902223115 BD Difco™ Neisseria Meningitidis Antiserum Group D BECTON, DICKINSON AND COMPANY GTJ 2016-04-28 00382902223214 BD Difco™ Neisseria Meningitidis Antiserum Poly Contains Groups A, B, C, D BECTON, DICKINSON AND COMPANY GTJ 2016-04-28
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