Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Covid-19 Antigen CARD Kit
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06931654312406
- Basic UDI-DI Code
- B-06931654312406
- Reference
- 1.13.0045
- Device Types
-
Single use Sterile Sterilization
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Fosun Diagnostics (Shanghai) Co., Ltd.
Additional Description
The Covid-19 Antigen CARD Kit is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid-protein in anterior nasal swab samples from individuals suspected of SARS-CoV-2 infection. The test can be used to assist in the diagnosis of the coronavirus infectious disease (COVID-19) caused by SARS-CoV-2. The Covid-19 Antigen CARD Kit is intended for self-use or lay user testing another in a non-laboratory setting.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | CeCert/082/W/E.1 | CeCert Sp. z o.o. | Expired |
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