Home GUDID 05051700006767 VaccZyme™ Human Anti-Haemophilus Influenzae type b
Primary DI 05051700006767
Brand VaccZyme™ Human Anti-Haemophilus Influenzae type b
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
OTC false
Sterile false
Single use false 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 DM exempt false Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 05051700020602 EXENT® Immunoglobulin Isotypes (GAM) Control Pack MSQ801.M 2025-11-27 05051700020640 EXENT® Diluent 1 IK876 2025-11-27 05051700020657 EXENT® Elution buffer 1 IK877 2025-11-27 05051700020664 EXENT® HCCA MALDI Matrix Pack IK820 2025-11-27 05051700020671 EXENT® Mass calibration standard 1 MSS801.M 2025-11-27 05051700020688 EXENT® Disposable MALDI plate pack IK819 2025-11-27 05051700020695 EXENT® Wash solution 1 IK822 2025-11-27 05051700020886 EXENT® Analyser IE800.A 2025-11-27 05051700021050 Immunoglobulin Isotypes (GAM) for the EXENT Analyser MSR801.M.A 2025-11-27 05051700021098 Optilite® CH50 Reagent NK095.OPT.A 2024-11-20 05051700019392 Optilite® Low Level Total Protein Controls NQ061.L.OPT 2024-10-30 05051700020534 Optilite® Low Level Total Protein Calibrator NC061.L.OPT 2024-10-30 05051700020558 Optilite® Low Level Total Protein Reagent NK061.L.OPT.A 2024-10-30 05051700021036 Optilite® IgG3 Kit (x10) LK008.10.OPT.A 2023-09-27 05051700021043 Optilite® IgG4 Kit (x10) LK009.10.OPT.A 2023-09-27 05051700016803 Freelite® Kappa AMR Check Fluid SD BP538.SD 2023-08-09 05051700016810 Freelite® Lambda AMR Check Fluid SD BP539.SD 2023-08-09 05051700002059 Freelite® Panel Sample Set BP228 2023-06-29
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 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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