421004

Organization name

Aesku.Diagnostics GmbH & Co. KG

SRN

DE-MF-000026925

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 18 countries total.

Trade name

not provided

UDI-DI code

04250289510707

Basic UDI-DI

B-04250289510707

Reference / catalog number

421004

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

AESKUBLOTS® Allergy is a membrane based enzyme immunoassay for quantitative detection of allergen-specific IgE antibodies against allergens/allergen mixtures and total IgE in human plasma or serum. Antigens are located as parallel lines at exactly defined positions on a nitrocellulose membrane. The assay permits a large number of tests to be conducted in parallel over a short period of time. The assay is a tool in diagnosis of type I allergy. This product is for IN VITRO DIAGNOSTIC use only. Thus, only staff trained and specially advised in methods of in vitro diagnostics may perform the kit.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• W01020204IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG