abioSCOPE Control

GUDID 07649996894106

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.

Abionic SA

Immunoassay instrument/analyser general performance control kit IVD

• Primary Device ID: 07649996894106
• NIH Device Record Key: d93189d9-47ad-4357-b2b7-226436e21fed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: abioSCOPE Control
• Version Model Number: P02.00045
• Company DUNS: 485727270
• Company Name: Abionic SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07649996894106 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-07
• Device Publish Date: 2025-09-29

Devices Manufactured by Abionic SA

• 07649996894090 - IVD CAPSULE Control PSP: 2025-10-07 "IVD CAPSULE Control PSP" is a control material (solution containing pancreatic stone protein) for the verification of the corre
• 07649996894106 - abioSCOPE Control: 2025-10-07The "abioSCOPE Control" is a control material (capsule) for the verification of the correct functioning of the abioSCOPE IVD analyser, rapid test/point-of-care.
• 07649996894106 - abioSCOPE Control: 2025-10-07 The "abioSCOPE Control" is a control material (capsule) for the verification of the correct functioning of the abioSCOPE IVD ana
• 07649996894014 - abioSCOPE: 2025-02-26 The abioSCOPE is a table top diagnostic device that measures analytes in biological samples, using testspecific capsules (IVD CA
• 07649996894021 - IVD CAPSULE PSP: 2025-02-26 The IVD CAPSULE PSP is a single-use, rapid in vitro diagnostic immunofluorescence assay for the semi-quantitative determination