Immunodiagnostic Systems SA
BE-MF-000015341 · Belgium · Liege
Immunodiagnostic Systems SA is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: IS-6010, IS-CS100, IS-CT100, IS-CW100.
Devices declared under this manufacturer
- Cartridge Checking System
- IDS-iSYS Cartridge Check System (CCS)
- IDS-iSYS System Liquid (Syst. l)
- IDS-iSYS Trigger Set
- IDS-iSYS Wash Solution (Wash S)
- System Liquid 5L
- Trigger Set
- Wash Solution 10L
- i-Track 10 Cartridge Check System
- i-Track 10 System Liquid
- i-Track 10 Trigger Set
- i-Track 10 Wash Solution
Catalogue references include 41401, 41403, IS-6010, IS-CT100, IS-CW100, TD IS-6010.
European nomenclature codes declared: W0201020185, W0102152099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | IMMUNODIAGNOSTIC SYSTEMS LTD. (GB) · FDA 8021924 |
| Devices in EUDAMED | 12 |
| Country of registration | Belgium |
Device-level evidence
| Devices with a numeric GTIN | 12 |
|---|---|
| Found in the U.S. device database | 4 |
| Share | 33.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | IMMUNODIAGNOSTIC SYSTEMS LIMITED |
What it holds in Canada
| Licences on record | 11 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 11 |
| First licensed | 2004-04-19 |
Licence types: Test Kit (10), System (1).
Licensed under: 25-HYDROXY VITAMIN DS EIA, GAMMA-B 1,25 - DIHYDROXY VITAMIN D, URINE CROSSLAPS (CTX-I) EIA, SERUM CROSSLAPS (CTX-I) ELISA, URINE CARTILAPS (CTX-II) EIA, N-MID OSTEOCALCIN ELISA.
North American profile: Both markets. Immunodiagnostic Systems SA is registered in both the United States and Canada.