Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 05204309137404
- Basic UDI-DI Code
- B-05204309137404
- Reference
- 1417-0860
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Medicon Hellas SA
Additional Description
Reagents for In Vitro quantitative automated measurement of the concentration of b2 Microglobulin (b2M) in samples of human serum or urine from the general patient population. Measurements of b2M are to be used as an aid in the prognosis of certain hematological malignancies and evaluation of renal function. This product has been packed for use with Siemens ADVIA® 1800/2400/XPT analyzers. For in vitro diagnostic use only by trained laboratory professionals.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102039002 | BETA2-MICROGLOBULIN |
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