BlueDot Chromatin 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

BlueDot Chromatin IgG

UDI-DI code

05425023680568

Basic UDI-DI

542502368BDCHROMATINFW

Reference / catalog number

CHRD-24

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

BlueDot Chromatin IgG is an immunodot kit intended for the detection, in human sera only, of IgG autoantibodies against Nucleosome, dsDNA and Histones antigens. This kit is intended to confirm results of homogeneous 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. The test is intended for confirmation of IFA positive population and IFA negative with strong suspicion of autoimmune disorder. 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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102100107HISTONES (H1, H2A, H3, H4,…HN)

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