FDA Device Establishments · JSON-LD · Markdown
FEI 3002806560 · Manufacture Medical Device · Status: Active
| FEI Number | 3002806560 |
|---|---|
| Owner / Operator | Roche Diagnostics Operations Inc. (#9039767) |
| Address | NONNENWALD 2, PENZBERG Bavaria, D-82377, DE |
| Mandatory US Agent | Roche Diagnostics Operations Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NJT |
| Regulation § (21 CFR) | 864.1860 |
| Proprietary names | VENTANA TROP2 (EPR20043) Rabbit Monoclonal Antibody; Special Stains Congo Red Stain Core Kit; VENTANA MTAP (SP530) Rabbit Monoclonal Antibody; VENTANA MTAP (SP530) Antibody; anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody; CONFIRM anti-Cytokeratin (AE1) Primary Antibody; CONFIRM anti-Vimentin (V9) Primary Antibody; VENTANA iView DAB Universal Kit (export); CONFIRM anti-CD68 (KP-1) Primary Antibody; CONFIRM anti-MITF (C5/D5) Mouse Monoclonal Primary Antibody |
Source: openFDA. Public-domain (CC0).