Eu Ivdr Eu Ivd Class B On The Market

IDS-iSYS CTX-I (CrossLaps®)

Devices (same UDI-DI)
2
Certificates
0
Countries
32
Notified Bodies
0

Basic Information

Primary DI
05060169690240
Basic UDI-DI Code
5060169690240WH
Reference
IS-3000
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class B
Status
On The Market

Additional Description

The IDS-iSYS CTX-I (CrossLaps®) assay is an 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 systems. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician. CTX I can be used as an indicator of bone resorption status as well as an aid in monitoring bone resorption changes during hormone replacement and Bisphosphonate therapies.

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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