AccessGUDID - DEVICE: BD Directigen™ Meningitis Test Negative Control Reagent (30382902523506)

GUDID

Device Identifier (DI) Information

Brand Name: BD Directigen™ Meningitis Test Negative Control Reagent
Version or Model: 252350
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 252350
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382902523506
Issuing Agency: GS1
Commercial Distribution End Date: May 20, 2016
Device Count: 4
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD Directigen™ Meningitis Test Negative Control Reagent

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
50401	Multiple meningitis-associated bacteria antigen IVD, control	A material which is used to verify the performance of an assay 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. Bacteria detected may include Haemophilus influenzae, Streptococcus pneumoniae, Neisseria meningitidis, Group B streptococcus or Escherichia coli (E. coli) bacteria.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GTJ	ANTISERA, ALL GROUPS, N. MENINGITIDIS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 9 Milliliter

Device Record Status

Public Device Record Key: 2f4feadb-1e2e-49c5-96be-76410383338b
Public Version Date: March 25, 2024
Public Version Number: 3
DI Record Publish Date: May 19, 2016