FDA Device Establishments · JSON-LD · Markdown

Sysmex Europe SE

FEI 3005626422 · Export Device to the United States But Perform No Other Operation on Device · Status: Active

FEI Number3005626422
Owner / OperatorSYSMEX CORPORATION (#9014170)
AddressMainstrasse 7, Neumunster Schleswig-Holstein, D-24539, DE
Mandatory US AgentSYSMEX AMERICA, INC
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)MVU
Regulation § (21 CFR)864.4020
Proprietary namesCyFlow IFN-gamma FITC; CyFlow CD45 Pacific Blue; CyFlow CD13 APC; CyFlow CD235a PE; CyFlow Kappa-LC Pacific Blue; CyFlow CD56 FITC; CyFlow CD56 PE; CyFlow CD13 PE; CyFlow Kappa-LC APC; CyFlow CD45 FITC

External sources

Source: openFDA. Public-domain (CC0).