Cardiolipin/ ß2-GPI IgG Dot

Organization name

D-tek s.a.

SRN

BE-MF-000024530

Manufacturer status

Active

Primary placement in Belgium; available across 17 countries total.

Trade name

Cardiolipin/ ß2-GPI IgG Dot

UDI-DI code

05425023687055

Basic UDI-DI

542502368BDAPS2U

Reference / catalog number

AD CBGD

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 Cardiolipin/ß2-GPI complex (CL/ß2-GPI) and ß2-GPI (isolated protein) antigens.This kit is intended to confirm results of patterns obtained by Enzyme Immunoassay techniques; the kit is intended as an aid in the diagnosis of several autoimmune diseases (for more details, see 11.5 of IFU Auto-antibodies diagnostic values).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 IFU. Detection of the different IgG auto-antibodies can be either qualitative (see point 10.1 of IFU), either semi-quantitative (see point 10.2 of IFU) 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.

• W0102100599ANTI-PHOSPHOLIP SYNDROME - OTHER

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