Eu Ivdr
Eu Ivd Class B
On The Market
🇧🇪 Belgium
Ustekinumab ELISA
Devices (same UDI-DI)
1
Certificates
0
Countries
4
Notified Bodies
0
Basic Information
- Primary DI
- 05430000412100
- Basic UDI-DI Code
- 5430000412710601Q7
- Reference
- 710601
- Device Types
-
Single use
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Advanced Practical Diagnostics
Additional Description
The Ustekinumab ELISA is an in vitro diagnostic medical device intended to be used by healthcare professionals for the quantitative measurement of ustekinumab in serum or plasma samples. The kit is designed for manual use and for use on open ELISA automates. Measurement of ustekinumab is intended to be performed for monitoring the drug level in the context of therapeutic drug monitoring in patients undergoing therapy with ustekinumab.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102080799 | AUTOIMMUNE DISEASE TDM - OTHER |
Available In Countries
🇧🇪 Belgium
🇱🇺 Luxembourg
🇳🇱 Netherlands
🇸🇮 Slovenia
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).
IDS ACE
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·14 countries
IDS SHBG
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·27 countries
IDS SHBG Control Set
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·27 countries
1,25-Dihydroxy Vitamin D RIA
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·12 countries
1,25-Dihydroxy Vitamin D RIA
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·12 countries
Serum CrossLaps® (CTX-I) ELISA
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·32 countries