ENA Screen Dot for BDI

Organization name

D-tek s.a.

SRN

BE-MF-000024530

Manufacturer status

Active

Primary placement in Belgium; available across 15 countries total.

Trade name

ENA Screen Dot for BDI

UDI-DI code

05425023687420

Basic UDI-DI

542502368BDDANAYE

Reference / catalog number

AD ENASDBD

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, Sm/RNP, SSA/Ro 60kD, SSB, Jo-1, Scl-70, PM-Scl 100 and CENP-A/B. 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 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, 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. 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.

• W0102100101ANA SCREENING

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