FDA Device Establishments · JSON-LD · Markdown
FEI 3004141078 · Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3004141078 |
|---|---|
| Owner / Operator | Roche Diagnostics Operations Inc. (#9039767) |
| Address | 4300 HACIENDA DRIVE, PLEASANTON, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | OWD |
| Proprietary names | cobas® EZH2 Mutation Test; cobas® EZH2 Analysis Package Software version 1; KIT COBAS 4800 EZH2 AMP/DET 24T IVD; SW C4800 EZH2 AP V1 CD |
Source: openFDA. Public-domain (CC0).