Home GUDID 00382902501602
BD Directigen™ Neisseria meningitidis Test Kit Groups A, C, Y and W135
Primary DI 00382902501602
Brand BD Directigen™ Neisseria meningitidis Test Kit Groups A, C, Y and W135
Company BECTON, DICKINSON AND COMPANY
Model 250160
Catalog number 250160
Device description BD Directigen™ Neisseria meningitidis Test Kit Groups A, C, Y and W135
Published 2016-07-07
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 GTI ANTISERA, FLUORESCENT, ALL GROUPS, N. MENINGITIDIS
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GTI Antisera, Fluorescent, All Groups, N. Meningitidis Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00382902501602 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 00382902501602 00382902501602 382902501602 0382902501602
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#