Devices (same UDI-DI)
1
Certificates
0
Countries
32
Notified Bodies
0
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Basic Information
- Primary DI
- 05060169695733
- Basic UDI-DI Code
- 5060169694064XH
- Reference
- IS-AI1702II
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Immunodiagnostic Systems Limited
Additional Description
The IDS PR3 II test is a chemiluminescent immunoassay (CLIA) for use on the IDS System for quantitative determination of the specific IgG antibodies directed against proteinase 3 (PR3) in samples of human serum or plasma (K3 EDTA, Sodium citrate). Results are to be used in conjunction with other clinical and laboratory data as an aid in the evaluation of ANCA-associated primitive systemic vasculitides and of Wegener’s granulomatosis (WG) in particular.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100403 | PR3 ANCA |
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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