Eu Ivdd
Eu Ivd General
On The Market
🇫🇮 Finland
Neonatal IRT FEIA
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- Primary DI
- 06438172214026
- Basic UDI-DI Code
- B-06438172214026
- Reference
- 6199831
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Labsystems Diagnostics Oy
Additional Description
This Neonatal IRT FEIA (fluorometric enzyme immunoassay) kit is for the quantitative determination of human immunoreactive Trypsinogen (IRT) in blood samples dried on filter paper as a primary test for screening of babies for cystic fibrosis (CF).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010199 | ENZYMES - 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