Immunodiagnostic Systems Limited
GB-MF-000015851 · United Kingdom · Boldon, Tyne & Wear
Immunodiagnostic Systems Limited is registered in the European database on medical devices as a manufacturer, with 208 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: AC-04F1, AC-05F1, AC-62F1, IDS-iSYS Diluent A, IS-10DC.
Authorised representative in the Union: Immunodiagnostic Systems SA.
Devices declared under this manufacturer
- 1,25-Dihydroxy Vitamin D EIA
- Alpha CrossLaps® (CTX-I) ELISA
- IDS Specific IgE (G008) Meadow grass
- IDS Androstenedione
- IDS Anti-TG
- IDS Specific IgE (E001) Cat dander
- IDS Specific IgE (M003) Aspergillus fumigatus
- IDS Specific IgE (T009) Olive
- IDS Urinary Cortisol Calibrator Set
- IDS-iSYS Diluent C
- IDS-iSYS Insulin-like Growth Factor Binding Protein-3 (IGFBP-3)
- IDS-iSYS Intact PINP
Showing 12 of 208 declared devices.
Catalogue references include IS-1E001, IS-1G008, IS-1M003, IS-1T009, IS-4000, IS-5400.
European nomenclature codes declared: W01020202, W0102152008, W0201020185, W0102152003, W0102152001, W0102152099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | IMMUNODIAGNOSTIC SYSTEMS LTD. (GB) · FDA 8021924 |
| Devices in EUDAMED | 208 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 208 |
|---|---|
| Found in the U.S. device database | 53 |
| Share | 25.5 % |
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 Limited is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HX 2333083-1 | supplemented | 2028-08-26 |