DIASpot MultiQUANT Neptune Liver10 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

DIASpot MultiQUANT Neptune Liver10 IgG

UDI-DI code

05425023688304

Basic UDI-DI

542502368BDQLIVERQV

Reference / catalog number

KAPDTLI10QN

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, of IgG autoantibodies against M2/nPDC, M2/OGDC-E2, M2/BCOADC-E2, M2/PDC-E2, gp210, sp100, LKM1, LC1, SLA and f-Actin antigens. 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 Neptune Instrument. Detection of the different IgG auto-antibodies is semi-quantitative. For a semi-quantification of the test results, it is necessary to use the system BlueScan scanner/Dr Dot Software.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102100703LKM1 AND RELATED PROTEINS ANTIBODIES

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