AccessGUDID - DEVICE: BD Directigen™ Neisseria meningitidis Test Kit Groups A, C, Y and W135 (00382902501602)

GUDID

Device Identifier (DI) Information

Brand Name: BD Directigen™ Neisseria meningitidis Test Kit Groups A, C, Y and W135
Version or Model: 250160
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 250160
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382902501602
Issuing Agency: GS1
Commercial Distribution End Date: September 18, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD Directigen™ Neisseria meningitidis Test Kit Groups A, C, Y and W135

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:	Yes
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?
50399	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GTI	ANTISERA, FLUORESCENT, 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
No Device Sizes

Device Record Status

Public Device Record Key: 99bab72e-3e02-4771-9dd3-6156e6660215
Public Version Date: October 26, 2023
Public Version Number: 4
DI Record Publish Date: July 07, 2016