Eu Ivdr Eu Ivd Class B On The Market

IS-AI1101

Devices (same UDI-DI)
1
Certificates
0
Countries
32
Notified Bodies
0

Basic Information

Primary DI
05060169693784
Basic UDI-DI Code
5060169693784YK
Reference
IS-AI1101
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class B
Status
On The Market

Additional Description

The IDS dsDNA IgG test is a chemiluminescent immunoassay (CLIA) for use on the IDS System for quantitative determination of the specific IgG antibodies directed against dsDNA in samples of human serum or plasma (EDTA). Results are to be used in conjunction with other clinical and laboratory data as an aid in the evaluation of systemic rheumatic autoimmune diseases.

CND Nomenclature Codes

Code Description
W0102100105 DS DNA - ANTIBODIES

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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