abioSCOPE Control

Name: abioSCOPE Control
Brand: Abionic SA
SKU: P02.00045

ABAbionic SA · Model P02.00045

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.

Intended use: 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.

Key tips

·When no category-specific guidance fits, default to the manufacturer's own service manual and the general troubleshooting method in the Engineer's Guide.
·Run an incoming and annual electrical safety test regardless of how niche the device is.

PM Checklist

Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.

·Follow the manufacturer's PM schedule
·Perform incoming and annual electrical safety testing per facility biomedical program

Technical Specs

Storage Environment Temperature: 2°C to 8°C
MRI safety: Labeling does not contain MRI Safety Information
Sterile: No
Single use: No
Prescription use: Rx only
FDA distribution status: In Commercial Distribution
Device type (GMDN): Immunoassay instrument/analyser general performance control kit IVD
FDA product classification: Single (Specified) Analyte Controls (Assayed And Unassayed)

Typical Location

Where this class of equipment is typically deployed - general reference, not this unit's own placement record.

Varies by device - check the unit's own manual for facility placement guidance

Documents & Manuals

View spec sheet (PDF)

No documents available for this device yet.

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