# Fujirebio Europe N.V.

FEI: 3002608770
Status: Active
Establishment types: Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner/operator: Fujirebio Diagnostics, Inc. (#10022860)

Address: TECHNOLOGIEPARK 6, GHENT Oost-Vlaanderen, B-9052, BE

Mandatory US Agent: Fujirebio Diagnostics, Inc.

## Products

Total registered: 1
Top product codes: OVK
Regulation §: 866.6010

Proprietary names: ADVIA 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

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223002608770%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3002608770