FDA Device Establishments · JSON-LD · Markdown
FEI 3002806559 · Manufacture Medical Device · Status: Active
| FEI Number | 3002806559 |
|---|---|
| Owner / Operator | Roche Diagnostics Operations Inc. (#9039767) |
| Address | SANDHOFER STRASSE 116, MANNHEIM Baden-Wurttemberg, D-68305, DE |
| Mandatory US Agent | Roche Diagnostics Operations Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | QVP, JJX |
| Regulation § (21 CFR) | 866.3983, 862.1660 |
| Proprietary names | Anti-SARS-CoV-2 S Elecsys E2G 300; Elecsys Anti-SARS-CoV-2 S |
Source: openFDA. Public-domain (CC0).