Bordetella parapertussis Agglutinating Serum

Basic Information

• Brand Name: Bordetella parapertussis Agglutinating Serum
• Primary DI: 05056080501833
• Version / Model: R30165601
• Company Name: REMEL EUROPE LIMITED
• Labeler DUNS: 232600853
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-21
• Public Version: 1
• Public Version Date: 2021-07-29
• Public Version Status: New
• Public Device Record Key: 6d0f4dc7-c636-4a41-8b60-85fb8a4598e8

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• 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
GOW	Antisera, Agglutinating, B. Parapertussis	Microbiology	866.3065	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62370	Multiple Bordetella species culture isolate antigen IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative detection of antigens from multiple species of Bordetella bacteria isolated by culture from a clinical specimen, using an agglutination method. It is commonly used for the detection of infection with Bordetella bacteria, which may include B. pertussis and B. parapertussis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05056080501833	GS1

Customer Contacts

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