LIAISON® Helicobacter Antigen Control Set

Basic Information

• Brand Name: LIAISON® Helicobacter Antigen Control Set
• Primary DI: 08056771602020
• Version / Model: 318201
• Company Name: Diasorin Inc.
• Labeler DUNS: 033429783
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-01
• Public Version: 1
• Public Version Date: 2018-11-01
• Public Version Status: New
• Public Device Record Key: 0c6bf720-fa94-4937-b7e8-7c01ef55df2d

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
50998	Helicobacter pylori antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from Helicobacter pylori bacteria in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08056771602020	GS1

Customer Contacts

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