Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

Human PAX1 Gene Methylation Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)

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

Basic Information

Primary DI
06972665701094
Basic UDI-DI Code
B-06972665701094
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

This kit is used to qualitatively detect the methylation of specific sites of PAX1 (Paired boxed gene1) gene in the DNA of cervical exfoliated cell samples . This kit is only used for the auxiliary diagnosis of patients with atypical squamous cells (ASC) and atypical glandular cells (AGC) as the result of TCT test of cervical exfoliated cells. should not be used as the sole basis for individualized treatment of patients. Clinicians should make a comprehensive judgment on the test results based on factors such as the patient's condition, drug indications, treatment response, and other laboratory test indicators.

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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