Eu Ivdr Eu Ivd Class B On The Market

IDS Beta CrossLaps® (CTX-I)

Devices (same UDI-DI)
3
Certificates
0
Countries
32
Notified Bodies
0

Basic Information

Primary DI
05060169695986
Basic UDI-DI Code
5060169695986ZF
Reference
IS-3000N
Device Types
New device
Regulation
Eu Ivdr
Classification
Eu Ivd Class B
Status
On The Market

Additional Description

IDS Beta CrossLaps® (CTX-I) assay is an automated in vitro diagnostic device intended for the quantitative determination of degradation products of C-terminal telopeptides of Type I collagen (CTX-I) in human serum or plasma on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the monitoring of bone resorption changes during therapeutic treatment in adult and paediatric populations.

CND Nomenclature Codes

Code Description
W0102060304 CROSS-LINKED C-TELOPEPTIDES

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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