Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
7 Kinds of Mutation in K-Ras Gene Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06970895476058
- Basic UDI-DI Code
- B-06970895476058
- Reference
- T021T012B0C2
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
Additional Description
This kit is intended for the qualitative detection of 7 common mutations in codons 12 and 13 of the K-ras in DNA extracts of tumor tissue samples from patients with lung cancer or colorectal cancer fixed in formalin and paraffin-embedded and can identify the types of mutations. This kit targeted and specified the 7 common mutations of K-ras gene (Table 1), including six base substitution mutations at codon 12 and one base substitution mutation at codon 13. It can be used for individualized molecular diagnosis to assist in individualized therapy for tumor patients.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0106010199 | MONOGENETIC DISORDERS 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