FDA Device Establishments · JSON-LD · Markdown
FEI 3009473156 · Manufacture Medical Device · Status: Active
| FEI Number | 3009473156 |
|---|---|
| Owner / Operator | RANDOX LABORATORIES, LTD. (#8020890) |
| Address | Meenmore, Dungloe Donegal, F94 TV06, IE |
| Mandatory US Agent | RANDOX LABORATORIES-US, LTD |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 5 |
| Product codes (top 20) | JJE, DJR, JXM, DJC, DJG |
| Regulation § (21 CFR) | 862.2160, 862.3620, 862.3170, 862.3610, 862.3650 |
| Proprietary names | Evidence MultiSTAT DOA Urine Multiplex; Evidence MultiSTAT |
Source: openFDA. Public-domain (CC0).