VIROLOGY - RT & POC - OTHER
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Basic Information
- Primary DI
- 06936791030022
- Basic UDI-DI Code
- B-06936791030022
- Reference
- XG030312
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Zhongshan Bio-Tech Co., Ltd.
Additional Description
The 2019-nCoV Antigen Test (Lateral Flow Method) is intended for the in vitro qualitative detection of the N-protein antigen from 2019-nCoV in oropharyngeal or nasopharyngeal swab specimens collected from individuals in suspected or cluster of COVID-19 cases, or other individuals who are in need of diagnosis or identification of 2019-nCoV infections. The 2019-nCoV Antigen Test should not be used solely for the diagnosis of 2019-nCoV infection, which should be done in combination with other diagnostic information from nucleic acid testing, imaging examination, etc. as well as medical history and contact history.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
Similar Devices
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