Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Detection Kit(Colloidal gold method)
Devices (same UDI-DI)
1
Certificates
1
Countries
3
Notified Bodies
1
Basic Information
- Primary DI
- 06974473306577
- Basic UDI-DI Code
- B-06974473306577
- Reference
- RQ00501001HK
- Device Types
-
Single use Sterilization
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Nanjing Synthgene Medical Technology Co., Ltd.
Additional Description
The product is used for the qualitative detection of SARS-CoV-2 infection. SARS-CoV-2 virus can cause death and complications. No instrument required. It can be used for the screening of infected patients. This kit is usedfor personal use by untrained layman.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-173/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
🇪🇸 Spain
🇫🇷 France
🇳🇱 Netherlands
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