VIROLOGY - RT & POC - OTHER
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
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 |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Self Testing) and regulation (EU IVDD).