Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
GENETIC TESTS - OTHER
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06937044500835
- Basic UDI-DI Code
- B-06937044500835
- Reference
- 1060099
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Ningbo HEALTH Gene Technologies Co., LTD.
Additional Description
The CYP2C19 Genotyping Kit is an in vitro diagnostic product for the identification of the CYP2C19 genotypes. It uses DNA extracted from peripheral blood samples as template to achieve three SNP loci (CYP2C19*2, *3, and *17) genotypes. The kit is a qualitative assay for use as an aid to clinicians/ physicians in determining therapeutic strategy for therapeutic drugs that are metabolized by the CYP2C19 gene product, specifically, *2, *3, and *17.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010699 | GENETIC TESTS - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).
BluBox
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries
ViroTrack Sero COVID-19 Total Ab
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURETM Haemoglobin F and A2 Calibrators
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ Haemoglobin F and A2 Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries