PROG-RIA-CT

Basic Information

• Brand Name: PROG-RIA-CT
• Primary DI: 05400569000490
• Version / Model: KIP1458
• Company Name: Diasource Immunoassays S.A. SA
• Labeler DUNS: 458777323
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-11
• Public Version: 1
• Public Version Date: 2020-09-21
• Public Version Status: New
• Public Device Record Key: 7b63d5be-ad07-47ee-bd4a-2e026484c8f9

Device Description

PROG-RIA-CT

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JLS	RADIOIMMUNOASSAY, PROGESTERONE	Clinical Chemistry	862.1620	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54323	Progesterone IVD, kit, radioimmunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of progesterone in a clinical specimen, using a radioimmunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05400569000490	GS1