AccessGUDID - DEVICE: BD Difco™ Bordetella Pertussis Antigen (00382902258513)

GUDID

Device Identifier (DI) Information

Brand Name: BD Difco™ Bordetella Pertussis Antigen
Version or Model: 225851
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 225851
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382902258513
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD Difco™ Bordetella Pertussis Antigen

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):	Yes
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?
50503	Multiple Bordetella species 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 species of Bordetella bacteria, which may include B. pertussis, B. parapertussis and/or B. bronchiseptica in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GOX	ANTIGEN, B. PERTUSSIS

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 5 Milliliter

Device Record Status

Public Device Record Key: 2d3facbe-eedf-446d-b1dc-35a7a77bb013
Public Version Date: June 28, 2024
Public Version Number: 2
DI Record Publish Date: May 25, 2018