FDA Device Establishments · JSON-LD · Markdown
FEI 3021047648 · Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3021047648 |
|---|---|
| Owner / Operator | Genomadix Inc (#10088570) |
| Address | 340 Legget Drive, Suite 180, Kanata (Ottawa) Ontario, K2K1Y6, CA |
| Mandatory US Agent | Emergo Global Representation LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NTI |
| Regulation § (21 CFR) | 862.3360 |
| Proprietary names | Genomadix Cube CYP2C19 System |
Source: openFDA. Public-domain (CC0).