FDA Device Establishments · JSON-LD · Markdown
FEI 3007125666 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3007125666 |
|---|---|
| Owner / Operator | MolecularMD Corporation, an ICON plc company (#10056701) |
| Address | 1341 SW Custer Drive, Portland, OR, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | OYX |
| Regulation § (21 CFR) | 866.6060 |
| Proprietary names | MRDx BCR-ABL Test Software; MRDx BCR-ABL Test; MRDx Test |
Source: openFDA. Public-domain (CC0).