abioSCOPE

Basic Information

• Brand Name: abioSCOPE
• Primary DI: 07649996894014
• Version / Model: P01.00007
• 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: c5a3081e-c4e7-43e8-b3ea-6a7047f501c3

Device Description

The abioSCOPE is a table top diagnostic device that measures analytes in biological samples, using testspecific capsules (IVD CAPSULE) intended for use with this instrument.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	862.2560	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57869	Ultraviolet-visible spectrophotometer IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used to measure the absorption or fluorescence of a solution(s) that has been irradiated with light of a specific wavelength, in the ultraviolet or visible range, to determine the concentration of a chemical or biological marker present in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07649996894014	GS1