FDA.reportPublic FDA data

Fujirebio Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30028951693002895169Fujirebio Inc.1N2027-01-011-3-14 Tanashioda, Chuo-ku Sagamihara-shi Kanagawa JP 252-0245

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04987270226964Beckman Coulter PK TP System - 226964800-223-0125xx@xx.xx
04987270226964Beckman Coulter PK TP System - 226964800-447-5852xx@xx.xx
04987270230466Lumipulse G Dilution Cartridges - 230466610-240-3800customersupport@fdi.com
04987270234440Soda Lime for LUMIPULSE System - 234440610-240-3800customersupport@fdi.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1935901470287116K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioSET2025-05-16
1935901378293477K190702Lumipulse G whole PTHCEW2019-08-30
1935901220056339K172713Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators setPRI2017-12-10
1935901919398870K171103Lumipulse G TSH-III Immunoreaction CartridgesJLW2017-07-28
1935901525085836K163544Lumipulse G ProlactinJIT2017-01-12
1935901327355536K163534Lumipulse G FSH-N CalibratorsJIT2017-01-13
1935901050003421K163521Lumipulse G LH CalibratorsJIT2017-01-12
1935901549802962K153361Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D CalibratorsMRG2016-04-15
1935901496795457K153145Lumipulse G TP-N Immunoreaction Cartridge SetLIP2016-07-05
1935901565074980K151378Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 CalibratorsOIU2015-11-24
1935901718059391K142895LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II CalibratorsLTK2015-05-21
1935901624035742DEN200072Lumipulse G ß-Amyloid Ratio (1-42/1-40)QSE2022-05-04
1935901135715901
1935901508983017

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JIT32017-01-13
PRI22017-12-10
LTK22015-05-21
SET12025-05-16
QSE12022-05-04
CEW12019-08-30
JLW12017-07-28
LIP12016-07-05
MRG12016-04-15
OIU12015-11-24

GUDID#

65 records. Showing 1-40. Next