GammaCoat™ Plasma Renin Activity

Basic Information

• Brand Name: GammaCoat™ Plasma Renin Activity
• Primary DI: 08056771601276
• Version / Model: CA1533
• Company Name: Diasorin Inc.
• Labeler DUNS: 033429783
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-08-23
• Public Version Status: Update
• Public Device Record Key: 0cc95534-d235-430e-a15c-a1c50bc5018d

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
54348	Renin IVD, kit, radioimmunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of renin (direct, active, or immunoreactive) in a clinical specimen, using a radioimmunoassay method. It is used to aid in the diagnosis of certain forms of hypertension.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08056771601276	GS1

Customer Contacts

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