Eu Ivdd
Eu Ivd General
On The Market
🇩🇪 Germany
ClinRep®
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-14100ES
- Basic UDI-DI Code
- B-14100ES
- Reference
- 14100
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- RECIPE Chemicals + Instruments GmbH
Additional Description
This ClinRep® Complete Kit is intended for the determination of 16 different antiepileptic drugs and clinically relevant metabolites (10-Hydroxy-Carbamazepine / Eslicarbazepine (as 10-Hydroxy-Carbamazepine), Carbamazepine, Carbamazepine-Epoxide, N-Desmethylmethsuximide, Ethosuximide, Felbamate, Lacosamide, Lamotrigine,Oxcarba(ma)zepine, Phenobarbital, Phenytoin, Primidone, Rufinamide, Sulthiame, Zonisamide) from serum and plasma by UHPLC. The kit components have to be used in accordance with corresponding user manual. The kit is not designed for combination with components from other manufacturers.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102080299 | CENTRAL NERVOUS SYSTEM TDM - OTHER |
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