830101-LV2

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

04250289513104

Basic UDI-DI

B-04250289513104

Reference / catalog number

830101-LV2

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® Food Intolerance is an in vitro semi-quantitative enzyme immunoassay for the simultaneous measurement of food specific IgG4 antibodies to 40 food extracts/extract mixtures in heparinized or Na-EDTA treated human capillary whole blood, venous whole blood, plasma or serum. It is intended for use as a point of care tool to support the diagnosis of patients presenting with various clinical symptoms associated with food intolerances. It is to be carried out by healthcare professionals experienced in the use of in vitro diagnostic methods.

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.

• W0102010106IMMUNOGLOBULIN G SUBCLASS REAGENTS