Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Rapid SARS-CoV-2 Antigen Test Card
Devices (same UDI-DI)
1
Certificates
1
Countries
4
Notified Bodies
1
Basic Information
- Primary DI
- 06921963712257
- Basic UDI-DI Code
- B-06921963712257
- Reference
- 1N40C5-2
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
Additional Description
Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | V9 061317 0006 | TÃœV SÃœD Product Service GmbH | Expired |
Available In Countries
🇩🇪 Germany
🇬🇷 Greece
🇪🇸 Spain
🇳🇴 Norway
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