Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
cTnI/CK-MB/Myo/D-Dimer/NT-proBNP Rapid Quantitative Test
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06933260208388
- Basic UDI-DI Code
- B-06933260208388
- Reference
- BT2107
- 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 cTnI/CK-MB/Myo/D-Dimer/NT-proBNP(Cardiac Troponin I/Isoenzyme of Creatine Kinase/Myoglobin/D-Dimer/N-terminal Pro-brainB-type) Rapid Quantitative Test is intended to quantify concentrations of cTnI, CK-MB, Myo, D-Dimer and NT-proBNP in human whole blood on Biotime FIA Analyzer by fluorescent immunoassay. It is used as an aid detection of AMI.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021699 | RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER |
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