FDA Device Establishments · JSON-LD · Markdown
FEI 3003559191 · Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3003559191 |
|---|---|
| Owner / Operator | Tecan Group AG (#9050992) |
| Address | 103 Seestrasse, Maennedorf Zurich, 8708, CH |
| Mandatory US Agent | Tecan U.S. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | JIT, JJX, CDZ |
| Regulation § (21 CFR) | 862.1150, 862.1660, 862.1680 |
| Proprietary names | Testosterone Luminescence Immunoassay; Unassayed Testosterone QC Material |
Source: openFDA. Public-domain (CC0).