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 Polymyositis/Scleroderma12 IgG

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

05425023681640

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

542502368BDDPMSCLLT

Reference / catalog number

PMS12DIV-24

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

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 Polymyositis/Scleroderma 12 IgG is an Immunodot kit intended for the detection, in human sera, of IgG autoantibodies against Jo-1, PL-7, PL-12, EJ, SRP, Mi-2, MDA-5, Tif1-gamma, Ku, PM/Scl 100, Scl-70, and SSA/Ro 52kD 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 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.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0102100108JO-1

• IVDR Class B medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.