Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

Colorectal Cancer Related Gene Mutation Detection Kit(High Throughput Sequencing)

XIAMEN SPACEGEN CO.,LTD. · 🇨🇳 China
Devices (same UDI-DI)
1
Certificates
0
Countries
32
Notified Bodies
0

Basic Information

Primary DI
06972665700332
Basic UDI-DI Code
B-06972665700332
Reference
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
Device Types
Single use Sterilization
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

16 Tests/kit,This kit is used to qualitatively detect 5 hot spot mutation genes (KRAS, NRAS, BRAF, PIK3CA, TP53), 2 chemotherapy-related genes (UGT1A1, DPYD) and ERBB2 copy number variation in paraffin-embedded tissue samples from colorectal cancer patients, and the detection of 34 microsatellite loci to analyze the microsatellite instability status of patients . The test results are only to evaluate the molecular characteristics of colorectal cancer patients to provide clinical reference, and should not be used as the sole basis for individualized treatment of colorectal cancer patients. Clinicians should consider the patient's medical condition, drug indications, treatment response and other laboratory test indicators, and other factors to make a comprehensive judgment on the test results.

CND Nomenclature Codes

Code Description
W010699 GENETIC TESTS - OTHER

Available In Countries

🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia 🇹🇷 Türkiye 🇬🇧 United Kingdom

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