FDA Device Establishments · JSON-LD · Markdown

Fujirebio Europe N.V.

FEI 3002608770 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active

FEI Number3002608770
Owner / OperatorFujirebio Diagnostics, Inc. (#10022860)
AddressTECHNOLOGIEPARK 6, GHENT Oost-Vlaanderen, B-9052, BE
Mandatory US AgentFujirebio Diagnostics, Inc.
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)OVK
Regulation § (21 CFR)866.6010
Proprietary namesADVIA Centaur XPT Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL) - Siemens; Atellica IM Cytokeratin Fragment 21-1 (CYFRA) - Siemens; ADVIA Centaur XPT Cytokeratin Fragment 21-1 (CYFRA) - Siemens; Atellica IM Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL) - Siemens

External sources

Source: openFDA. Public-domain (CC0).