EURIA Gastrin

Basic Information

• Brand Name: EURIA Gastrin
• Primary DI: 07340058412015
• Version / Model: MD302
• Catalog Number: MD302
• Company Name: Euro-Diagnostica AB
• Labeler DUNS: 559894501
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-12
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 25530434-9568-404d-8d85-72729411afa0

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
CGC	Radioimmunoassay, Gastrin	Clinical Chemistry	862.1325	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54189	Gastrin IVD, kit, radioimmunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of gastrin in a clinical specimen, using a radioimmunoassay method. It is used to aid in the investigation and treatment of disorders associated with abnormal gastrin production [e.g., recurrent peptic ulcers, gastrin-producing tumours (gastrinomas) and Zollinger-Ellison syndrome (ZES)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07340058412015	GS1