Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Malaria P.v Antigen Rapid Test
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06933260206322
- Basic UDI-DI Code
- B-06933260206322
- Reference
- BT0102001
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
Additional Description
The Malaria P.v Antigen Rapid Test is a rapid lateral flow immunoassay for the qualitative detection of Plasmodium lactate dehydrogenase (pLDH) specific to Plasmodium vivax (P.v) in human whole blood specimen.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105050209 | PLASMODIUM (MALARIA) |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).
BluBox
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries
ViroTrack Sero COVID-19 Total Ab
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURETM Haemoglobin F and A2 Calibrators
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ Haemoglobin F and A2 Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries