FDA Device Establishments · JSON-LD · Markdown
FEI 3014607865 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3014607865 |
|---|---|
| Owner / Operator | RANDOX LABORATORIES, LTD. (#8020890) |
| Address | 30 RANDALSTOWN ROAD, ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, BT41 4FL, GB |
| Mandatory US Agent | RANDOX LABORATORIES-US, LTD |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | DCN, JIX |
| Regulation § (21 CFR) | 866.5270, 862.1150 |
| Proprietary names | C-Reactive Protein_2 (CRP_2) Calibrators; C-Reactive Protein_2 (CRP_2) Reagents; Atellica CH C-Reactive Protein_2 Calibrators (CRP_2 CAL); Atellica CH C-Reactive Protein_2 (CRP_2) |
Source: openFDA. Public-domain (CC0).