Devices (same UDI-DI)
4
Certificates
0
Countries
7
Notified Bodies
0
Basic Information
- Primary DI
- 08429577002828
- Basic UDI-DI Code
- 84295779045XX
- Reference
- 9.045.020.00.000
- Device Types
-
Single use
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- OPERON, S.A.
Additional Description
One-step test for the detection of GDH (glutamate dehydrogenase) from Clostridium difficile in stool samples in plastic device format, kit of 20 tests. All the necessary materials included.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090106 | CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC |
Available In Countries
🇦🇹 Austria
🇨🇿 Czechia
🇪🇸 Spain
🇫🇷 France
🇮🇹 Italy
🇵🇱 Poland
🇵🇹 Portugal
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