DIASpot Neptune ANA12 Screen 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 Neptune ANA12 Screen IgG

UDI-DI code

05425023688137

Basic UDI-DI

542502368BDDANAYE

Reference / catalog number

KAPDTANA12SN

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 following antigens: Sm, RNP 68kD/A/C, Sm/RNP, SSA/Ro 60kD, SSB, Jo-1, Scl-70, PM-Scl 100, Ku, CENP-A/B, PCNA and Mi-2. This kit is intended to confirm results of anti-nuclear 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 confirmation of IFA positive population and IFA negative with strong suspicion of autoimmune disorder. 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 can be either qualitative, either semi-quantitative. For a semi-quantification of the test results, it is necessary to use the BlueScan scanner system and the Dr Dot software.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102100101ANA SCREENING

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