VIROLOGY - RT & POC - OTHER
Basic Information
- Primary DI
- 06936791030039
- Basic UDI-DI Code
- B-06936791030039
- Reference
- XG030311
- 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 produced by Zhongshan Biotech Co., Ltd. is an immunochromatographic reagent for the in vitro qualitative detection of SARS-CoV-2 antigen in human anterior nasal swab specimens from individuals who are asymptomatic or suspected of SARS-CoV-2 infection. Testing of asymptomatic individuals should be limited to contacts of confirmed or potential cases or other epidemiological causes of suspected COVID-19 infection and should be followed by additional molecular confirmatory testing. (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 | CeCert/057/W/E.1 | CeCert Sp. z o.o. | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Self Testing) and regulation (EU IVDD).