Home GUDID 00382902519607 BD Directigen™ S. pneumoniae Test
Primary DI 00382902519607
Brand BD Directigen™ S. pneumoniae Test
Company BECTON, DICKINSON AND COMPANY
Model 251960
Catalog number 251960
Device description BD Directigen™ S. pneumoniae Test
Published 2018-05-25
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 GWC ANTISERA, ALL TYPES, STREPTOCOCCUS PNEUMONIAE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GWC Antisera, All Types, Streptococcus Pneumoniae Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00382902519607 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 00382902519607 00382902519607 382902519607 0382902519607
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 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 05713106105573 ImmuView S. pneumoniae and L. pneumophila urinary antigen test Ssi Diagnostica A/S GWC 2022-10-25 05713106549919 ImmuLex Strep-B kit, 10 x 1.5 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106663981 ImmuLex S. pneumoniae Type 4, 1.5 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106732656 ImmuLex Streptococcus Group Kit, 6 x 1.5 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106732663 Pneumococcus Factor 6d serum, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106768549 Pneumococcus Type 1 serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106768563 Pneumococcus Type 2 serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106768587 Pneumococcus Type 3 serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106768594 Pneumococcus Type 4 serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106768648 Pneumococcus Type 5 serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106768662 Pneumococcus Type 8 serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106768679 Pneumococcus Type 14 serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106768693 Pneumococcus Type 20 serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106768716 Pneumococcus Group 6 serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106768730 Pneumococcus Group 7 serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106768778 Pneumococcus Group 10 serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106768822 Pneumococcus Group 11 serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106769119 Pneumococcus Group 12 serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106769133 Pneumococcus Group 15 serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106769140 Pneumococcus Group 17 serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106769157 Pneumococcus Group 18 serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106769164 Pneumococcus Group 33 serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106769171 Pneumococcus Factor 6b serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106769188 Pneumococcus Factor 7b serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106769201 Pneumococcus Factor 9d serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106769218 Pneumococcus Factor 9e serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106769232 Pneumococcus Factor 19b serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106769249 Pneumococcus Factor 19c serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106769256 Pneumococcus Factor 22b serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01 05713106769270 Pneumococcus Factor 23b serum high titer, 1 mL Ssi Diagnostica A/S GWC 2021-08-01
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