AccessGUDID - DEVICE: BD Difco™ Bordetella Parapertussis Antiserum (00382902231011)

GUDID

Device Identifier (DI) Information

Brand Name: BD Difco™ Bordetella Parapertussis Antiserum
Version or Model: 223101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 223101
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382902231011
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 Parapertussis Antiserum

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?
50504	Multiple Bordetella species antigen IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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
GOW	ANTISERA, AGGLUTINATING, B. PARAPERTUSSIS

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: 1 Milliliter

Device Record Status

Public Device Record Key: cba4e3f8-2fc8-431b-9d8b-bc2d009f0ade
Public Version Date: June 28, 2024
Public Version Number: 2
DI Record Publish Date: May 25, 2018