NA

Basic Information

• Brand Name: NA
• Primary DI: 05056080500102
• Version / Model: R30952901
• Company Name: REMEL EUROPE LIMITED
• Labeler DUNS: 232600853
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2023-08-18
• Public Version Status: Update
• Public Device Record Key: fb4bf3d1-4f48-4503-a9b6-26ab1152259d
• Distribution End Date: 2023-07-31

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
GNC	Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.	Microbiology	866.3550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
51535	Multiple Salmonella species total antibody IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to one or multiple species of Salmonella bacteria in a clinical specimen, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05056080500102	GS1

Customer Contacts

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