Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Rapid 2019-nCoV IgG/IgM Combo Test Card
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06921963712059
- Basic UDI-DI Code
- B-06921963712059
- Reference
- 1N38C2
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
Additional Description
Rapid 2019-nCoV IgG/IgM Combo Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. Rapid 2019-nCoV IgG/IgM Combo Test Card is a supplement detection for COVID-19 suspected infected patients besides nucleic acid test, which could greatly raise the accuracy of the detection for COVID-19.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
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