Stiffman GADI + GADII IgG Dot for BDI

Organization name

D-tek s.a.

SRN

BE-MF-000024530

Manufacturer status

Active

Primary placement in Belgium; available across 17 countries total.

Trade name

Stiffman GADI + GADII IgG Dot for BDI

UDI-DI code

05425023687444

Basic UDI-DI

542502368BDDGADYB

Reference / catalog number

AD GADBD

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 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 D-tek’s GADIV-24 is for the detection of Stiffman Syndrome only. The test is intended for a large, routine population. This kit is strictly reserved for professional use in clinical analysis laboratories. This kit is strictly foreseen as an automated test and can only be used in a BlueDiver Instrument Model I or II (hereinafter named BDI I or BDI II respectively). Detection of the different IgG autoantibodies can be either qualitative or semi-quantitative. For a semi-quantification of the test results, it is necessary to use the BlueScan scanner system and the Dr Dot software. This system is not included in the BDI I but is included in the BDI II.

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

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