FDA Device Establishments · JSON-LD · Markdown
FEI 3012113276 · Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3012113276 |
|---|---|
| Owner / Operator | SpeeDx Pty Ltd (#10057454) |
| Address | Suite 102, National Innovation Centre, 4 Cornwallis Street, Eveleigh New South Wales, 2015, AU |
| Mandatory US Agent | SpeeDx Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | JJX |
| Regulation § (21 CFR) | 862.1660 |
| Proprietary names | ResistancePlus GC Control; Positive Control Flu/RSV/SARS; ResistancePlus MG Positive Control; Positive Control HSV/VZV/TP |
Source: openFDA. Public-domain (CC0).