FDA Device Establishments · JSON-LD · Markdown
FEI 3007500635 · Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device · Status: Active
| FEI Number | 3007500635 |
|---|---|
| Owner / Operator | IMMUNODIAGNOSTIC SYSTEMS LTD. (#8021924) |
| Address | Rue Ernest Solvay 101, Liege, 4000, BE |
| Mandatory US Agent | Euroimmun US Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | JJE |
| Regulation § (21 CFR) | 862.2160 |
| Proprietary names | IDS-iSYS Cartridge Check System (CCS); IDS Immunocleaner; IDS-iSYS Wash Solution (Wash S); IDS-iSYS System Liquid (Syst l); IDS-iSYS Trigger Set; IDS-iSYS Cuvettes; IDS-iSYS D-Sorb Solution |
Source: openFDA. Public-domain (CC0).