FDA.reportPublic FDA data

Fujirebio Inc. Ube Facility

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146430413014643041Fujirebio Inc. Ube Facility1N2026-01-01203-152, Aza-Ushiake, Oaza-Yoshiwa Ube-shi Yamaguchi JP 759-0134

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3244971323341184K971502SERODIA TP-PAGMT1997-11-13
3244971718059391K142895LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II CalibratorsLTK2015-05-21
3244971271170604BK200476
3244971494908573BK070030

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LTK12015-05-21
GMT11997-11-13