FDA Device Establishments · JSON-LD · Markdown
FEI 3004185580 · Manufacture Device in the United States for Export Only · Status: Active
| FEI Number | 3004185580 |
|---|---|
| Owner / Operator | EPITOPE DIAGNOSTICS, INC. (#9059077) |
| Address | 17034 Camino San Bernardo, SAN DIEGO, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NYI |
| Regulation § (21 CFR) | 866.6040 |
| Proprietary names | SKT-056 Cancer Antigen 15-3 (CA15-3) CLIA Kit |
Source: openFDA. Public-domain (CC0).