FDA Device Establishments · JSON-LD · Markdown
FEI 3002807663 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3002807663 |
|---|---|
| Owner / Operator | BECKMAN COULTER, INC. (#2050012) |
| Address | 454-32 HIGASHINO,NAGAIZUMI-CHO, SUNTO-GUN Shizuoka, 411-0931, JP |
| Mandatory US Agent | Beckman Coulter, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 4 |
| Product codes (top 20) | CEM, JJE, CGZ, JGS |
| Regulation § (21 CFR) | 862.1600, 862.2160, 862.1170, 862.1665 |
| Proprietary names | B86445 DxC 700 AU for Direct Track Sampling; B86446 DxC 700 AU for Direct Track Sampling with ISE; B86443 DxC 700 AU; B86444 DxC 700 AU with ISE |
Source: openFDA. Public-domain (CC0).