FDA Device Establishments · JSON-LD · Markdown
FEI 1000206808 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 1000206808 |
|---|---|
| Owner / Operator | BECKMAN COULTER, INC. (#2050012) |
| Address | LISMEEHAN, O CALLAGHANS MILLS Clare, --, IE |
| Mandatory US Agent | Beckman Coulter, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | LTJ, MTF |
| Regulation § (21 CFR) | 866.6010 |
| Proprietary names | Access Hybritech PSA Calibrators (P/N: 37205 MN MFG); Access Hybritech PSA (P/N: 37200 MN and IE MFG); Access Hybritech PSA Sample Diluent (P/N: 37206 MN MFG); Access Hybritech PSA (P/N: C22845 MN MFG) |
Source: openFDA. Public-domain (CC0).