ImmunoCAP Allergen f225, Pumpkin

PAPhadia AB · Model 14-4433-01

ImmunoCAP Allergen f225, Pumpkin.

Intended use: A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergen(s) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to screen for allergies associated with certain conditions (e.g., food intolerance).

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): Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
FDA product classification: SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
Manufacturer support: +469999999999 · xx@xx.xx

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

No documents available for this device yet.

Safety & Recalls

Synced live from the FDA openFDA API.

RECALL
The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
RECALL
The firm found this lot of ImmunoCAP Allergen Ri206, American Cockroach does not contain sufficient levels of some cockroach allergens e.g. tropomyosin. Approximately 2% of the positive samples have a risk to fall below the Limit of Quantization (o .1 kUA/L).

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