BlueDiverDot ANCA+GBM 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

BlueDiverDot ANCA+GBM IgG

UDI-DI code

05425023681350

Basic UDI-DI

542502368BDDANCA4F

Reference / catalog number

ANCAGDIV-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

BlueDiver Dot ANCA+GBM IgG is an Immunodot kit intended for the detection, in human sera only, of IgG autoantibodies against the following antigens : MPO, PR3 and GBM. 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. 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 auto-antibodies can be either qualitative (see point 10.1 of the IFU), either semi-quantitative (see point 10.2 of the IFU). 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 (see point 4 of the IFU).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102100401ANCA SCREENING

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