FDA Device Establishments · JSON-LD · Markdown
FEI 1000414342 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 1000414342 |
|---|---|
| Owner / Operator | EVER Pharma Jena (#10055008) |
| Address | Otto-Schott-Str. 15, Jena Thuringia, 07745, DE |
| Mandatory US Agent | Roche Diagnostics Operations Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 5 |
| Product codes (top 20) | JGS, CEM, JIL, CGZ, JIX |
| Regulation § (21 CFR) | 862.1665, 862.1600, 862.1340, 862.1170, 862.1150 |
| Proprietary names | ISE Standard High 10x3ML; ISE Standard Low 10x3ML |
Source: openFDA. Public-domain (CC0).