BlueDot GAD 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 GAD IgG

UDI-DI code

05425023680704

Basic UDI-DI

542502368BDGADZC

Reference / catalog number

GAD-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 GAD IgG is an immunodot kit intended for the detection, in human sera only, of IgG autoantibodies against the antigens GAD I and GAD II. This kit is intended to confirm results obtained by Enzyme Immunoassay techniques; the kit is intended as an aid in the diagnosis of several autoimmune diseases. Please note that this kit is for the detection of the Stiffman Syndrome only. Detection of the different IgG autoantibodies can be either qualitative or semi-quantitative. 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.

• W0102100299NEURO-AUTO-IMMUNE DISEASE - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification