FDA Device Establishments · JSON-LD · Markdown
FEI 3000303338 · Manufacture Medical Device · Status: Active
| FEI Number | 3000303338 |
|---|---|
| Owner / Operator | SENTINEL CH. SpA (#9025279) |
| Address | VIA ROBERT KOCH, 2, MILANO, 20152, IT |
| Mandatory US Agent | Diagnostic Oncology CRO, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NDW |
| Regulation § (21 CFR) | 862.3560 |
| Proprietary names | Multigent Lithium Assay; Alinity c Lithium Reagent Kit |
Source: openFDA. Public-domain (CC0).