820101

Trade name

not provided

UDI-DI code

04250289510851

Basic UDI-DI

B-04250289510851

Reference / catalog number

820101

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

AESKUCARE® Allergy is an in vitro semi-quantitative enzyme immunoassay for the parallel measurement of allergen-specific human IgE antibodies to 20 allergens and allergen mixtures in heparinized or Na-EDTA blood, venous or capillary blood, plasma or serum. The test is intended to be a point of care tool for comprehensive first line in vitro allergy diagnostics in conjunction with other clinical findings, and is to be carried out by healthcare professionals experienced in the use ofin vitro diagnostic methods.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W01020204IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG

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• CW010

  EUDAMED did not publish a description for this code.

No certificate specifically references this device's Basic UDI-DI.