IVD CAPSULE Control PSP

Basic Information

• Brand Name: IVD CAPSULE Control PSP
• Primary DI: 07649996894090
• Version / Model: P02.00040
• Company Name: Abionic SA
• Labeler DUNS: 485727270
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-29
• Public Version: 1
• Public Version Date: 2025-10-07
• Public Version Status: New
• Public Device Record Key: 1dcb2208-b313-48f2-8c81-cb6efb223506

Device Description

"IVD CAPSULE Control PSP" is a control material (solution containing pancreatic stone protein) for the verification of the correct performance of the PSP IVD test "IVD CAPSULE PSP", rapid test/point-of-care.

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: 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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
67551	Pancreatic stone protein (PSP) 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 pancreatic stone protein (PSP), also known as lithostathine-1-alpha or reg-1-alpha, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07649996894090	GS1