Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Rapid Cardiac Panel Test Card
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06921963711434
- Basic UDI-DI Code
- B-06921963711434
- Reference
- 1J04C2
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
Additional Description
Rapid Cardiac Panel Test Card is an immunochromatography based one step in vitro test. It is designed for qualitative determination of cardiac troponin I (cTnI), CK-MB and Myoglobin in human serum, plasma or whole blood specimens as an aid in the diagnosis of myocardial infarction.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160706 | MULTIPLE CARDIAC MARKERS - RT & POC |
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