BlueDiver Instrument 2

Organization name

D-tek s.a.

SRN

BE-MF-000024530

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Belgium; available across 18 countries total.

Trade name

BlueDiver Instrument 2

UDI-DI code

05425023685044

Basic UDI-DI

5425023685044W7

Reference / catalog number

BLUEDIVER2

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

Automated ImmunoAssay Instrument dedicated to the carrying out of in vitro diagnosis tests. It performs the various steps of samples pipetting, incubation, washing, drying and reading of D-tek’s immunodot strips, from the deposit of the sample to the final reading of the strips. The instrument can also manage other kits with equivalent BlueDiver design (strips and cartridges) The maximum capacity of the Instrument is of 24 strips which are incubated simultaneously. The Instrument is 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
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