Devices (same UDI-DI)
1
Certificates
0
Countries
32
Notified Bodies
0
Basic Information
- Primary DI
- 08436040326732
- Basic UDI-DI Code
- 843604032VCM03301C9
- Reference
- VCM033
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- Status
- On The Market
- Manufacturer
- Vircell, S.L
Additional Description
Indirect chemiluminescent immunoassay (CLIA) to test IgG antibodies against Zika virus in human serum/plasma. The device is intended to be used with general population with suspected infection or exposure to the microorganism and pregnant women. The test is a qualitative and automated assay, intended to be used as an aid to diagnosis.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040630 | ZIKA VIRUS |
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
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).
CREATININE
Device
EU IVDR
·
Eu Ivd Class C
·Medicon Hellas SA·On the market·1 country
CREATININE
Device
EU IVDR
·
Eu Ivd Class C
·Medicon Hellas SA·On the market·1 country
MH Guide
Device
EU IVDR
·
Eu Ivd Class C
·Molecular Health GmbH·On the market·2 countries
CREATININE
Device
EU IVDR
·
Eu Ivd Class C
·Medicon Hellas SA·On the market·1 country
CREATININE
Device
EU IVDR
·
Eu Ivd Class C
·Medicon Hellas SA·On the market·1 country
CREATININE
Device
EU IVDR
·
Eu Ivd Class C
·Medicon Hellas SA·On the market·1 country