FDA Device Establishments · JSON-LD · Markdown
FEI 2245578 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 2245578 |
|---|---|
| Owner / Operator | ABBOTT LABORATORIES (#1415939) |
| Address | 400 College Road East, Princeton, NJ, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 2 |
| Product codes (top 20) | MMI, JJE |
| Regulation § (21 CFR) | 862.1215, 862.2160 |
| Proprietary names | i-STAT 1 analyzer; i-STAT hs-TnI cartridge |
Source: openFDA. Public-domain (CC0).