Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
2019-nCOV IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06971792050532
- Basic UDI-DI Code
- B-06971792050532
- Reference
- K460216D
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Hangzhou Realy Tech Co.,Ltd.
Additional Description
The 2019-nCOV IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG & IgM antibody of Coronavirus Disease 2019 in human whole blood, serum, or plasma as an aid in the diagnosis of COVID-19 infections.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
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