BTM Test

Organization name

möLab GmbH

SRN

DE-MF-000022941

Manufacturer status

Active

10 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW009

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• CW007

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• CW032

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• CW167

  EUDAMED did not publish a description for this code.
• CW159

  EUDAMED did not publish a description for this code.
• CW160

  EUDAMED did not publish a description for this code.
• CW163

  EUDAMED did not publish a description for this code.
• CW168

  EUDAMED did not publish a description for this code.
• CW999

  Handle and dispose of all used test kits and samples as if they were potentially infectious material. Observe the precautions for microbiological waste. Wear disposable gloves whilst performing the test.

Primary placement in Germany; available across 32 countries total.

Trade name

BTM Test

UDI-DI code

D-0230006TT

Basic UDI-DI

B-0230006TT

Reference / catalog number

0230006

Issuing entity

EUDAMED

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The mö-screen BTM (Bladder Tumour Marker) Test is a rapid immunochromatographic test for the detection of the bladder tumour marker BTM (hCFHrp) and haemoglobin in urine. It is intended for professional use only.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102030101BLADDER TUMOUR ANTIGEN

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