ASCA Screen IgA + 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

ASCA Screen IgA + IgG Dot

UDI-DI code

05425023687031

Basic UDI-DI

542502368BDCROHN99

Reference / catalog number

AD ASCASD

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 are Immunodot kits intended for the detection, in human sera, of IgG and/ or IgA autoantibodies against Saccharomyces cerevisiae phosphopeptido-Mannan antigen. 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.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 (see point 10.1 of the IFU), either semi-quantitative (see point 10.2 of the 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.

• W0102109018SACCHAROMYCES CEREVISIAE ANTIBODIESInactive

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