Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
AFP Rapid Quantitative Test
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06933260208494
- Basic UDI-DI Code
- B-06933260208494
- Reference
- BT2402
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
Additional Description
The Biotime AFP Rapid Quantitative Test is intended to quantify the concentration of AFP inhuman serum, plasma on Biotime FIA Analyzer by fluorescent immunoassay. The test is used as an aid detection of liver cancer.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102039001 | ALPHAFETOPROTEIN |
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