Home GUDID 05051700006767 VaccZyme™ Human Anti-Haemophilus Influenzae type b Enzyme Immunoassay Kit
Primary DI 05051700006767
Brand VaccZyme™ Human Anti-Haemophilus Influenzae type b Enzyme Immunoassay Kit
Company THE BINDING SITE GROUP LIMITED
Model MK016
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name GRP Antisera, All Types, H. Influenza
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GRP Antisera, All Types, H. Influenza Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05051700006767 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05051700006767 05051700006767 5051700006767
GMDN Terms# Term, Definition table Term Definition Haemophilus influenzae culture isolate antigen IVD, antibody One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative detection of antigens from one or multiple strains of Haemophilus influenzae bacteria isolated by culture from a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 347045614 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05051700021104 Freelite® Human Kappa Free Kit for use on the Roche cobas® c Systems LK016.CB.A 2026-02-02 05051700021111 Freelite® Human Lambda Free Kit for use on the Roche cobas® c Systems LK018.CB.A 2026-02-02 05051700006316 Freelite® Human Kappa Free Kit for use on the HITACHI 911/912/917/Modular P LK016.H 2016-09-24 05051700006323 Freelite® Human Kappa Free Kit for use on the Beckman Coulter IMMAGE®/IMMAGE®800 LK016.IM 2016-09-24 05051700006439 Freelite® Human Lambda Free Kit for use on the Hitachi 911/912/917/Modular P LK018.H 2016-09-24 05051700010269 Total Haemolytic Complement RC001.1 2016-09-24 05051700010276 Total Haemolytic Complement RC001.2 2016-09-24 05051700010283 Total Haemolytic Complement RC001.3 2016-09-24 05051700010399 Human IgG Subclass Single Dilution BINDARID™ Kit - Bulk Kit RK021 2016-09-24 05051700010504 Human C1 Inactivator BINDARID™ Radial Immunodiffusion Kit RN019.3 2016-09-24 05051700010559 Human Complement C4 ‘NL’ BINDARID™ Radial Immunodiffusion Kit RN025.3 2016-09-24 05051700010764 Human Plasminogen ’NL’ BINDARID™ Radial Immunodiffusion Kit RN065.3 2016-09-24 05051700010917 Human IgG1 Subclass Single Dilution BINDARID™ Kits RN106.3 2016-09-24 05051700010924 Human IgG2 Subclass Single Dilution BINDARID™ Kits RN107.3 2016-09-24 05051700010931 Human IgG3 Subclass Single Dilution BINDARID™ Kits RN108.3 2016-09-24 05051700010948 Human IgG3 Subclass Single Dilution BINDARID™ Kits RN109.3 2016-09-24 05051700016919 Hevylite® Human IgA Kappa Kit for use on the Siemens BN™II NK623.T.A 2016-09-24 05051700016926 Hevylite IgA Lambda Kit for Siemens BNII NK624.T.A 2016-09-24 05051700018715 Freelite® Human Lambda Free Control Pack For use on the Beckman Coulter IMMAGE™ NQ018.IM 2017-06-05 05051700018739 Freelite® Human Kappa Free Control Pack For use on the Beckman Coulter IMMAGE™/ NQ016.IM 2017-06-05
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 15060392377601 Mast Assure Antisera MAST GROUP LIMITED GRP 2022-04-06 15060392376338 Mast Assure Antisera MAST GROUP LIMITED GRP 2021-09-22 04048474025309 Haemophilus influenza B IgG ELISA DRG Instruments Gesellschaft mit beschränkter Haftung GRP 2019-06-06 00404847425307 Haemophilus influenza B IgG ELISA DRG Instruments Gesellschaft mit beschränkter Haftung GRP 2019-06-06 15060392377564 Mast Assure Antisera MAST GROUP LIMITED GRP 2018-12-12 15060392377571 Mast Assure Antisera MAST GROUP LIMITED GRP 2018-08-17 07350049850115 Phadebact Haemophilus Test Mkl Diagnostics AB GRP 2016-11-17 05056080501079 NA REMEL EUROPE LIMITED GRP 2016-09-24 05056080501086 NA REMEL EUROPE LIMITED GRP 2016-09-24 05056080501093 NA REMEL EUROPE LIMITED GRP 2016-09-24 05056080501109 NA REMEL EUROPE LIMITED GRP 2016-09-24 05056080501116 NA REMEL EUROPE LIMITED GRP 2016-09-24 05056080501123 NA REMEL EUROPE LIMITED GRP 2016-09-24 05713106034620 H. influenzae Type b serum, 1 mL Ssi Diagnostica A/S GRP 2016-09-13 05713106852057 ImmuLex H. influenzae type b antiserum, 1,5 mL Ssi Diagnostica A/S GRP 2016-09-13 05713106914601 ImmuLex H. influenzae type a antiserum, 1,5 mL Ssi Diagnostica A/S GRP 2016-09-13 05713106914618 ImmuLex H. influenzae type c antiserum, 1,5 mL Ssi Diagnostica A/S GRP 2016-09-13 05713106914625 ImmuLex H. influenzae type d antiserum, 1,5mL Ssi Diagnostica A/S GRP 2016-09-13 05713106914649 ImmuLex H. influenzae type e antiserum, 1,5mL Ssi Diagnostica A/S GRP 2016-09-13 05713106914656 ImmuLex H. influenzae type f antiserum, 1,5mL Ssi Diagnostica A/S GRP 2016-09-13 05713106914670 ImmuLex H. influenzae polyv. Antiserum, 1,5mL Ssi Diagnostica A/S GRP 2016-09-13 00382902223719 BD Difco™ Haemophilus influenzae Antiserum Poly Contains Types a, b, c, d, e, f BECTON, DICKINSON AND COMPANY GRP 2016-07-07 00382902522607 BD Directigen™ H. influenzae type b Test Kit BECTON, DICKINSON AND COMPANY GRP 2016-05-19 00382902278917 BD Difco™ Haemophilus influenzae Antiserum Type c BECTON, DICKINSON AND COMPANY GRP 2016-04-29 00382902279013 BD Difco™ Haemophilus influenzae Antiserum Type d BECTON, DICKINSON AND COMPANY GRP 2016-04-29 00382902279112 BD Difco™ Haemophilus Influenzae Antiserum Type e BECTON, DICKINSON AND COMPANY GRP 2016-04-29 00382902279211 BD Difco™ Haemophilus Influenzae Antiserum Type f BECTON, DICKINSON AND COMPANY GRP 2016-04-29 00382902223610 BD Difco™ Haemophilus Influenzae Antiserum Type b BECTON, DICKINSON AND COMPANY GRP 2016-04-28 00382902225010 BD Difco™ Haemophilus Influenzae Antiserum Type a BECTON, DICKINSON AND COMPANY GRP 2016-04-28
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