FDA Device Establishments · JSON-LD · Markdown
FEI 3003045237 · Manufacture Medical Device · Status: Active
| FEI Number | 3003045237 |
|---|---|
| Owner / Operator | ABBOTT LABORATORIES (#1415939) |
| Address | Kjelsaasveien 161, Oslo, NO-0884, NO |
| Mandatory US Agent | Alere Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | PDJ |
| Regulation § (21 CFR) | 862.1373 |
| Proprietary names | Afinion HbA1c Dx; Alere Afinion AS100 Analyzer |
Source: openFDA. Public-domain (CC0).