Eu Ivdd
Eu Ivd General
On The Market
🇫🇮 Finland
Neonatal Biotinidase
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06438172218017
- Basic UDI-DI Code
- B-06438172218017
- Reference
- 6199821
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Labsystems Diagnostics Oy
Additional Description
Neonatal Biotinidase kit is for enzymatic determination of human biotinidase enzyme activity from blood samples dried on filter paper. Intended for newborn screening of biotinidase deficiency. For professional laboratory use only. Both manual use and NS2400 automate use.
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