Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
2-IN-1 COVID-19 Antigen Rapid Test Device (Nasal&Saliva)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06976753472989
- Basic UDI-DI Code
- B-06976753472989
- Reference
- A151601D
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Hangzhou Cybereagen Biotech Co., Ltd.
Additional Description
The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Nasal & Saliva) is an in vitro diagnostic test for the qualitative detection Nucleoprotein of Coronavirus Disease 2019 in human Oropharyngeal saliva and nasal swab, using the rapid immunochromatographic method as an aid in the diagnosis of SARS-Cov-2 infections. The identification is based on the monoclonal antibodies specific for the novel coronavirus antigen. It will provide information for clinical doctors to prescribe correct medications.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
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