Devices (same UDI-DI)
1
Certificates
0
Countries
32
Notified Bodies
0
Basic Information
- Primary DI
- 05060169693777
- Basic UDI-DI Code
- 5060169693777YN
- Reference
- IS-AI1002
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Immunodiagnostic Systems Limited
Additional Description
The IDS ENA Screen assay is a chemiluminescent immunoassay (CLIA) for use on the IDS system for qualitative determination of the specific IgG antibodies directed against SS-A/Ro (60 kDa and 52 kDa), SS-B/La, Sm, U1-snRNP (70 kDa, A and C), Scl-70, and Jo-1 antigens 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 |
|---|---|
| W0102100102 | ENA SCREENING |
Available In Countries
🇦🇹 Austria
🇧🇪 Belgium
🇧🇬 Bulgaria
🇨🇾 Cyprus
🇨🇿 Czechia
🇩🇪 Germany
🇩🇰 Denmark
🇪🇪 Estonia
🇬🇷 Greece
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
ðŸ‡ðŸ‡· Croatia
ðŸ‡ðŸ‡º Hungary
🇮🇪 Ireland
🇮🇸 Iceland
🇮🇹 Italy
🇱🇮 Liechtenstein
🇱🇹 Lithuania
🇱🇺 Luxembourg
🇱🇻 Latvia
🇲🇹 Malta
🇳🇱 Netherlands
🇳🇴 Norway
🇵🇱 Poland
🇵🇹 Portugal
🇷🇴 Romania
🇸🇪 Sweden
🇸🇮 Slovenia
🇸🇰 Slovakia
🇹🇷 Türkiye
🇬🇧 United Kingdom
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