Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Carbohydrate Antigen CA50 Assay Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06954376005371
- Basic UDI-DI Code
- B-06954376005371
- Reference
- 69543760F000546G
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Beijing Leadman Biochemistry Co., Ltd.
Additional Description
This test kit is intended for in vitro quantitative determination of CA50 content in human serum. It is mainly used for dynamic monitoring of patients with malignant tumors, applying to the auxiliary evaluation of disease process or therapeutic effect. However, it cannot be used as the basis for early or definite diagnosis of malignant tumors. This kit is not available for tumor screening in the general population.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102030104 | CANCER ANTIGEN 50 |
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