DIASpot Celiac IgG

Organization name

D-tek s.a.

SRN

BE-MF-000024530

Manufacturer status

Active

Primary placement in Belgium; available across 17 countries total.

Trade name

DIASpot Celiac IgG

UDI-DI code

05425023688069

Basic UDI-DI

542502368BDCELIACE4

Reference / catalog number

KAPDTENDG

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

This kit is an immunodot kit intended for the detection, in human sera only, of IgG autoantibodies against deamidated Gliadin (d-Gliadin) and t-Transglutaminase (tTG) antigens. This kit is intended to confirm results of patterns obtained by immunofluorescence, the screening and reference method in autoimmunity; the kit is intended as an aid in the diagnosis of several autoimmune diseases. It must be emphasized that anti-gliadin IgG antibodies are of limited value for the diagnosis of Celiac disease, due to low specificity. However, they are considered as an indicative risk feature and should be tested systematically in known or suspected IgA-deficient patients. The test is intended for a large, routine population. This kit is strictly reserved for professional use in clinical analysis laboratories. Prior training is strongly recommended (please contact your distributor). It can only be used manually on a platform shaker or in an open automated immunodot processing system, programmed according to the pipetting scheme described in point 9.2 of the IFU. Detection of the different IgG auto-antibodies can be either qualitative, either semi-quantitative when read on the BlueScan/DrDOT reading system.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102100602TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST

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