Eu Ivdr
Eu Ivd Class B
On The Market
🇧🇪 Belgium
Anti-Infliximab ELISA
Devices (same UDI-DI)
1
Certificates
0
Countries
4
Notified Bodies
0
Basic Information
- Primary DI
- 05430000412049
- Basic UDI-DI Code
- 5430000412710101PE
- Reference
- 710101
- Device Types
-
Single use
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Advanced Practical Diagnostics
Additional Description
The Anti-Infliximab ELISA is an in vitro diagnostic medical device intended to be used by healthcare professionals for the quantitative measurement of antibodies to infliximab in serum or plasma samples. The kit is designed for manual use and for use on open ELISA automates. Measurement of antibodies to infliximab is intended to be performed for assessing the immune response against the drug in the context of therapeutic drug monitoring in patients undergoing therapy with infliximab.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102080799 | AUTOIMMUNE DISEASE TDM - OTHER |
Available In Countries
🇧🇪 Belgium
🇱🇺 Luxembourg
🇳🇱 Netherlands
🇸🇮 Slovenia
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