FDA.reportPublic FDA data

Fujirebio Europe N.V.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96158373002608770Fujirebio Europe N.V.1N2027-01-01TECHNOLOGIEPARK 6 GHENT Oost-Vlaanderen BE B-9052

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1720241262246476P160016VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)OBF2017-03-14
1720241470287116K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioSET2025-05-16
1720241015013447
1720241689578601
1720241064490153
1720241508983017
1720241552319926

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SET12025-05-16
OBF12017-03-14