Eu Ivdr
Eu Ivd Class B
On The Market
🇪🇸 Spain
HEPATITIS E VIRCLIA® IgG MONOTEST
Devices (same UDI-DI)
1
Certificates
0
Countries
32
Notified Bodies
0
Basic Information
- Primary DI
- 08436040326947
- Basic UDI-DI Code
- 843604032VCM06601DD
- Reference
- VCM066
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Vircell, S.L
Additional Description
Indirect chemiluminescent immunoassay (CLIA) to test IgG antibodies against hepatitis E virus in human serum/plasma. The device is intended to be used with general population with suspected infection or exposure to the microorganism. The test is a quantitative and automated assay, intended to be used as an aid to diagnosis.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105020504 | HEV ANTIBODY IGG |
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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