3254-025

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.

• CW032

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

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.

Primary placement in Czechia; available across 6 countries total.

Trade name

not provided

UDI-DI code

08595223925411

Basic UDI-DI

85952239000016X9

Reference / catalog number

3254-025

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 CYP2C19 in vitro diagnostic kit is intended for the qualitative determination of status (genotyping) of rs4244285 (allele CYP2C19*2), rs4986893 (allele CYP2C19*3) and rs12248560 (allele CYP2C19*17) polymorphisms of human gene CYP2C19 encoding cytochrome P450 2C19 precursor. The detection of these polymorphisms serves as an aid to determine slow, normal or rapid metabolizers among patients using pharmaceuticals from the range of antidepressants, anticoagulants and antifungal agents. 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.

• W0106030104CYP2C19

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