FDA Device Establishments · JSON-LD · Markdown
FEI 3011781554 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3011781554 |
|---|---|
| Owner / Operator | Genetic Signatures Limited (#10049463) |
| Address | 7 Eliza St, Newtown New South Wales, 2042, AU |
| Mandatory US Agent | Genetic Signatures US Ltd |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | OOI, PCH |
| Regulation § (21 CFR) | 862.2570, 866.3990 |
| Proprietary names | EasyScreen Gastrointestinal Parasite Detection Kit |
Source: openFDA. Public-domain (CC0).