CORONAVIRUS [obsolete from 2025-01-01]
Basic Information
- Primary DI
- 06930317801295
- Basic UDI-DI Code
- B-06930317801295
- Reference
- DNK-1419-1
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
Additional Description
The 2019-nCoV IgG/IgM Rapid Test is based on rapid immunochromatographic test. It is used for qualitative detection of 2019 Novel Coronavirus (also known as SARS-CoV-2) IgG and IgM antibody in human whole blood (Sodium citrate, EDTA, Sodium heparin) /serum/plasma (Sodium citrate, EDTA, Sodium heparin). The 2019-nCoV IgG/IgM Rapid Test is intended for use as an aid in identifying individuals with antibodies against SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist after infection and if the presence of antibodies confers protective immunity. The 2019-nCoV IgG/IgM Rapid Test should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to trained laboratory professionals use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).