FDA Device Establishments · JSON-LD · Markdown
FEI 3009972873 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3009972873 |
|---|---|
| Owner / Operator | Biocartis NV (#10055159) |
| Address | Generaal De Wittelaan 11B, Mechelen Antwerpen, 2800, BE |
| Mandatory US Agent | Biocartis US, Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | PRE |
| Regulation § (21 CFR) | 866.3215 |
| Proprietary names | SeptiCyte RAPID |
Source: openFDA. Public-domain (CC0).