FDA Device Establishments · JSON-LD · Markdown
FEI 3008794764 · Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device · Status: Active
| FEI Number | 3008794764 |
|---|---|
| Owner / Operator | EXBIO Praha, a.s. (#10055443) |
| Address | Nad Safinou II 341, Vestec Praha-Zapad, 25250, CZ |
| Mandatory US Agent | SYSMEX AMERICA, INC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | MVU |
| Regulation § (21 CFR) | 864.4020 |
| Proprietary names | CyFlow CD56 PE; CyFlow CD27 FITC; CyFlow CD8 PerCP; CyFlow CD3 APC; CyFlow CD19 Alexa Fluor 700; CyFlow CD56 FITC; CyFlow CD10 FITC; CyFlow CD38 FITC; CyFlow CD117 PE; CyFlow CD10 PE |
Source: openFDA. Public-domain (CC0).