Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
VIROLOGY - RT & POC - OTHER
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06975146600008
- Basic UDI-DI Code
- B-06975146600008
- Reference
- 1 test/package
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- BioDetect（Xiamen）Biotechnology Co., Ltd.
Additional Description
Rapid SARS-CoV-2 Antigen Test Card is a one-step in vitro test based on immunochromatography. It aims to quickly and qualitatively determine the SARS-CoV-2 virus antigen in anterior nasal (front nose) swabs of individuals. Rapid SARS-CoV-2 Antigen Test Card is intended for infection detection. Rapid SARS-CoV-2 Antigen Test Card detects the SARS-CoV-2 nucleocapsid protein (N protein), and all known SARS-CoV-2 variants do not affect the product performance.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-038/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
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