BD Difco™ FA Bordetella Pertussis Antiserum

Basic Information

• Brand Name: BD Difco™ FA Bordetella Pertussis Antiserum
• Primary DI: 00382902235910
• Version / Model: 223591
• Catalog Number: 223591
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-25
• Public Version: 2
• Public Version Date: 2022-07-15
• Public Version Status: Update
• Public Device Record Key: 5d989de5-606a-4e5a-8e11-9f1bad0ad4b5
• Distribution End Date: 2021-05-29

Device Description

Vial Fa Bordetella Pertussis 5Ml

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GOZ	ANTISERA, FLUORESCENT, B. PERTUSSIS	Microbiology	866.3065	1

GMDN Terms

Code	Name	Definition	Implantable	Status
50501	Multiple Bordetella species antigen IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from multiple species of Bordetella bacteria, which may include B pertussis, B. parapertussis and/or B. bronchiseptica in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382902235910	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius