3255-050

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 8 countries total.

Trade name

not provided

UDI-DI code

08595223925527

Basic UDI-DI

85952239000020WY

Reference / catalog number

3255-050

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 DPYD in vitro diagnostic kit is intended for the qualitative determination of status (genotyping) of the rs3918290 (c1905+1G>A; *2A), rs55886062 (c1679T>G; *13), rs56038477 (c1236G>A; HapB3) and rs67376798 (c2846A>T) polymorphisms of human gene DPYD encoding enzyme dihydropyrimidine dehydrogenase [NADP(+)]. The detection of these polymorphisms serves as an aid to identify patients at risk of adverse events among patients using fluoropyrimidine chemotherapeutics. 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
• Software identification