Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Carbohydrate Antigen 19-9(CA19-9) Assay Reagent Kit(CMIA)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06971792054417
- Basic UDI-DI Code
- B-06971792054417
- Reference
- C2KA003
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Hangzhou Realy Tech Co.,Ltd.
Additional Description
The Carbohydrate Antigen 19-9(CA19-9) Assay Reagent Kit(CMIA) is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of carbohydrate antigen 19-9 (CA19-9) in human serum or plasma.
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