IVD CAPSULE PSP

Basic Information

• Brand Name: IVD CAPSULE PSP
• Primary DI: 07649996894021
• Version / Model: P02.00026
• Company Name: Abionic SA
• Labeler DUNS: 485727270
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-18
• Public Version: 1
• Public Version Date: 2025-02-26
• Public Version Status: New
• Public Device Record Key: c4161c27-8416-4df0-9b85-766be13e3996

Device Description

The IVD CAPSULE PSP is a single-use, rapid in vitro diagnostic immunofluorescence assay for the semi-quantitative determination of the concentration of pancreatic stone protein (PSP).

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: 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SCX	Immunoassay For Host Biomarkers Of Sepsis	Microbiology	866.3215	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62553	Pancreatic stone protein (PSP) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials 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, using a fluorescent immunoassay method. It is used to help assess a patient’s risk of developing sepsis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07649996894021	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius