3217-050

Organization name

GENERI BIOTECH s.r.o.

SRN

CZ-MF-000018857

Manufacturer status

Active

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

• CW007

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Czechia; available across 1 country total.

Trade name

not provided

UDI-DI code

08595223921727

Basic UDI-DI

85952239000018XD

Reference / catalog number

3217-050

Issuing entity

GS1

Risk category

IVDR Class C

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

INTENDED PURPOSE: The gb PHARM TPMT in vitro diagnostic kit is intended for the qualitative determination of status (genotyping) of the rs1800462, rs180046 and rs1142345 polymorphisms of human gene TPMT encoding enzyme thiopurine S-methyltransferase. The detection of these polymorphisms serves as an aid to identify patients at risk of adverse events when using thiopurine drugs. The detection is performed from human genomic DNA samples extracted from peripheral blood. The device is intended for testing in Caucasian population. It is intended for laboratory professional use by trained healthcare professionals. The kit requires manual preparation of reagents and samples, which are then analysed with the use of real-time PCR cycler instrument.

Additional information URL

https://www.generi-biotech.com/download/

Clinical sizes

No clinical sizes registered for this device.

• W0106010499POLYMORPHISM TESTS - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
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