Oxoid Reaction Cards

Basic Information

• Brand Name: Oxoid Reaction Cards
• Primary DI: 05032384012954
• Version / Model: DR0500G
• Company Name: OXOID LIMITED
• Labeler DUNS: 365355452
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-18
• Public Version: 1
• Public Version Date: 2024-06-26
• Public Version Status: New
• Public Device Record Key: 5c04ddbc-b2fb-4604-a32e-b05211bcc90f

Device Characteristics

• Single Use: Yes
• 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
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	866.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65293	Microbial-isolate agglutination assay reaction card IVD	A non-reactive surface in the form of a card intended to be used as a background area where an agglutination assay reaction can be detected and visualized (e.g., by colour contrast) upon addition of specific reagents, antigens, or antibodies [not included], for the qualitative and/or quantitative detection of microbial species isolated by culture from a clinical specimen. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05032384012954	GS1