Eu Ivdd
Eu Ivd General
On The Market
🇳🇱 Netherlands
Anti-Epileptic Drugs Expanded Panel Reagent Set
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-4030PAEDX4T
- Basic UDI-DI Code
- B-4030PAEDX4T
- Reference
- 4030 P AEDX
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Diagnotix B.V.
Additional Description
The intended use (medical purpose) of this device is to aid in the Therapeutic Drug Monitoring (TDM) of several anti-epileptic drugs by the determination of these anti-epileptic medications in plasma, performed by automated quantitative LC-MS/MS assay technology.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102080299 | CENTRAL NERVOUS SYSTEM TDM - OTHER |
| W0102080215 | LEVETIRACETAM |
| W0102080214 | ZONISAMIDE |
| W0102080213 | TOPIRAMATE |
| W0102080212 | LAMOTRIGINE |
| W0102080211 | GABAPENTIN |
| W0102080210 | VALPROIC ACID |
| W0102080208 | PHENYTOIN |
| W0102080207 | PHENOBARBITAL |
| W0102080202 | ETHOSUXIMIDE |
| W0102080201 | CARBAMAZEPINE |
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