Eu Ivdr
Eu Ivd Class B
On The Market
🇪🇸 Spain
Simple GDH-Toxins
Devices (same UDI-DI)
4
Certificates
0
Countries
8
Notified Bodies
0
Basic Information
- Primary DI
- 08429577007878
- Basic UDI-DI Code
- 84295779065Y5
- Reference
- 9.065.020.15.000
- Device Types
-
Single use
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- OPERON, S.A.
Additional Description
One-step immunochromatographic test combining two strips for the qualitative differential detection of GDH (glutamate dehydrogenase) in one strip, and Toxins A and B from Clostridium difficile in different bands in the second strip, in human faecal samples, kit of 20 test. Basic material included.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090106 | CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC |
Available In Countries
🇦🇹 Austria
🇩🇪 Germany
🇬🇷 Greece
🇪🇸 Spain
🇵🇱 Poland
🇵🇹 Portugal
🇷🇴 Romania
🇸🇰 Slovakia
Related Devices
The Basic UDI-DI associated with this device has 4 devices in total. Below are some other devices sharing the same Basic UDI-DI.
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