BLUESCAN1/ BlueScan Scanner + DR DOT LIC4/ Dr Dot Software

Organization name

D-tek s.a.

SRN

BE-MF-000024530

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Belgium; available across 18 countries total.

Trade name

BLUESCAN1/ BlueScan Scanner + DR DOT LIC4/ Dr Dot Software

UDI-DI code

05425023685013

Basic UDI-DI

5425023685013VU

Reference / catalog number

BLUESCAN1 + DR DOT LIC4

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The BlueScan Scanner and DrDot Software System is an instrument intended to help the semi-quantitative interpretation of IVD products. The scanner has been specifically developed for the reading of the strips with “BlueDiver” design. Based on the image of the scanned strips, the Dr Dot software converts the intensity of each dot/line into a numerical value. The Bluescan Scanner and Dr Dot software are intended only for laboratory professional use and must be used only by trained personnel

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0201020101AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)

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