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
- 06936791020030
- Basic UDI-DI Code
- B-06936791020030
- Reference
- XG0310-01
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Zhongshan Bio-Tech Co., Ltd.
Additional Description
The COVID-19 antigen rapid testing kit (colloidal gold) produced by Zhongshan Bio-tech Co., Ltd. is a colloidal gold immunochromatographic reagent for the in vitro qualitative detection of SARS-CoV-2 antigen in human anterior nasal swab specimens of asymptomatic people or people suspected of COVID-19 infection (aged 18-65, as for people under 18 or above 65, specimen collection and testing need to be assisted by an adult) in a non-medical setting by lay persons.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-264/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
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