Home GUDID 00382902522607
BD Directigen™ H. influenzae type b Test Kit
Primary DI 00382902522607
Brand BD Directigen™ H. influenzae type b Test Kit
Company BECTON, DICKINSON AND COMPANY
Model 252260
Catalog number 252260
Device description BD Directigen™ H. influenzae type b Test
Published 2016-05-19
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use 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 00382902522607 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00382902522607 00382902522607 382902522607 0382902522607
GMDN Terms# Term, Definition table Term Definition Multiple meningitis-associated bacteria antigen IVD, kit, agglutination A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple bacteria associated with meningitis, in a clinical specimen, using an agglutination method. Bacteria detected may include Haemophilus influenzae, Streptococcus pneumoniae, Neisseria meningitidis, Group B streptococcus or Escherichia coli (E. coli) bacteria.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 122561087 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 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 05051700006767 VaccZyme™ Human Anti-Haemophilus Influenzae type b Enzyme Immunoassay Kit THE BINDING SITE GROUP LIMITED GRP 2016-09-24 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 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