ANA Granular 12Ag 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

ANA Granular 12Ag IgG Dot

UDI-DI code

05425023687017

Basic UDI-DI

542502368BDGRANULARQV

Reference / catalog number

AD ANAGR12D

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 SSA/Ro 60kD, SSB, Scl-70, Mi-2, Ku, TIF1-γ, SAE1/2, NXP-2, RNA Polymerase III, DFS-70, Sm/RNP and Sm antigens. This kit is intended to confirm results of speckled/granular 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.

• W0102100112SS-A

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