Eu Ivdd
Eu Ivd Self Testing
On The Market
🇹🇷 Türkiye
Vision Biyoteknoloji Araştırma Geliştirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited Şirketi
Devices (same UDI-DI)
1
Certificates
1
Countries
10
Notified Bodies
1
Basic Information
- Primary DI
- 08682835877921
- Basic UDI-DI Code
- B-08682835877921
- Reference
- V2004R190
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
Additional Description
VISION COVID-19 Rapid Antigen Test Kit is the double-antibody sandwich method for the qualitative detection of SARS-CoV-2 antigens in human nasal swab samples. Nasal swab samples can be self-administered by individuals older than 15 years of age. Individuals aged 2 to 15 years should be sampled and tested by an adult (≥ 18 years). This kit is not suitable for children under 2 years old. You can test yourself at any time, whether you have symptoms or not. This kit is designed for self-testing and can be used as an auxiliary tool for diagnosing current COVID-19 infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103030501 | OTHER ANTIGEN TYPING REAGENTS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-520/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. |
Available In Countries
🇧🇪 Belgium
🇧🇬 Bulgaria
🇩🇪 Germany
🇩🇰 Denmark
🇪🇸 Spain
🇫🇷 France
🇮🇹 Italy
🇵🇱 Poland
🇷🇴 Romania
🇹🇷 Türkiye
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