abioSCOPE Control

Basic Information

• Brand Name: abioSCOPE Control
• Primary DI: 07649996894106
• Version / Model: P02.00045
• 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: d93189d9-47ad-4357-b2b7-226436e21fed

Device Description

The "abioSCOPE Control" is a control material (capsule) for the verification of the correct functioning of the abioSCOPE IVD analyser, rapid test/point-of-care.

Device Characteristics

• Single Use: No
• 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
65954	Immunoassay instrument/analyser general performance control kit IVD	A collection of reagents of known reactivity (negative or positive) intended to be used to verify the overall performance of an immunoassay instrument/analyser [e.g., enzyme immunoassay (EIA) analyser]. It is not specific to an analyte.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07649996894106	GS1

Storage Conditions

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