Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
VIROLOGY - RT & POC - OTHER
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06936791020023
- Basic UDI-DI Code
- B-06936791020023
- Reference
- XG0303001
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Zhongshan Bio-Tech Co., Ltd.
Additional Description
The COVID-19 antigen rapid testing kit (colloidal gold) produced by Zhongshan Biotech Co., Ltd. is a colloidal gold immunochromatographic reagent for the in vitro qualitative detection of SARS-CoV-2 antigen in human nasopharyngeal swab (NPS) and oropharyngeal swab (OPS) specimens. The test result of this kit is mainly used clinically for supplementary diagnosis of SARS-CoV-2 infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
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