Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
CANCER ANTIGEN 19-9
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06974671100045
- Basic UDI-DI Code
- B-06974671100045
- Reference
- DR-CM-A013
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Darui Biotechnology Co., Ltd.
Additional Description
This kit is intended for quantitative detection of carbohydrate antigen 19-9 (CA19-9) in human serum. It is mainly used for dynamic monitoring of patients with malignant tumors to assist in evaluating disease progression or treatment effects. It should not be used as the basis for the early diagnosis or confirmation of malignant tumors or used for tumor screening in the general population.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102030103 | CANCER ANTIGEN 19-9 |
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