IMAGEN Influenza Virus A and B

Basic Information

• Brand Name: IMAGEN Influenza Virus A and B
• Primary DI: 05032384502981
• Version / Model: K610511-2
• Company Name: OXOID LIMITED
• Labeler DUNS: 365355452
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-30
• Public Version: 1
• Public Version Date: 2025-01-07
• Public Version Status: New
• Public Device Record Key: 0780d4a0-e342-4426-a89d-31eafcf33016

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: No
• 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
GNX	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C	Microbiology	866.3330	1

GMDN Terms

Code	Name	Definition	Implantable	Status
49117	Influenza A/B virus 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 influenza A virus and/or influenza B virus 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	05032384502981	GS1

Customer Contacts

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