FDA.reportPublic FDA data

Fujirebio Diagnostics, Inc.

Matched from indexed company URL: FUJIREBIO INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16436211643621Fujirebio Diagnostics, Inc.1Y2026-01-01940 Crossroads Blvd Seguin TX US 78155
25216252521625Fujirebio Diagnostics, Inc.1Y2026-01-01201 Great Valley Parkway Malvern PA US 19355
30146430413014643041Fujirebio Inc. Ube Facility1N2026-01-01203-152, Aza-Ushiake, Oaza-Yoshiwa Ube-shi Yamaguchi JP 759-0134
30272735653027273565Fujirebio Diagnostics AB1N2026-01-01Gemenskapens gata 7 Molndal Vastra Gotaland SE SE-431 53

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
00869164000086Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio - CL0073610-240-3800customersupport.us@fujirebio-us.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3244971323341184K971502SERODIA TP-PAGMT1997-11-13
863241323341184K971502SERODIA TP-PAGMT1997-11-13
863241032140280K820499FITC ANTI-RABIES MONOCLONAL GLOBULINGOI1982-04-16
706461470287116K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioSET2025-05-16
706461348858458K160090Lumipulse G ROMAONX2016-05-16
863241718059391K142895LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II CalibratorsLTK2015-05-21
3244971718059391K142895LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II CalibratorsLTK2015-05-21
863242054661100K110641FUJIREBIO DIAGNOSTICS VITAMIN D CONTROLJJX2011-05-27
863242067597942K110436FDI GLUCOSE CONTROL SOLUTION FOR AVIVAJJX2011-04-20
706461646006825K103358ROMA (HE4 EIA + ARCHITECT CA 125 II)ONX2011-09-01
3170181416518199K101809FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20JJY2010-10-05
863241567728122K083549ABT GLUCOSE CONTROL SOLUTIONJJX2008-12-22
863241455528424K080273AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTIONJJX2008-08-08
863241766562277K070649SMS GLUCOSE CONTROL, MODEL 2120061JJX2007-04-12
863241439758080K063855LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047JJX2007-02-01
863241376656331K060481LIBERTY GLUCOSE CONTROL SOLUTIONJJX2006-03-09
863241839041125K060426LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041JJX2006-03-09
863241695090271K053061EMIT 2000 CYCLOSPORINE SPECIFIC ASSAYMKW2006-02-06
706461648105640H060004
706461624035742DEN200072Lumipulse G ß-Amyloid Ratio (1-42/1-40)QSE2022-05-04
863241315713011BK960092
706461107622988BK960070
863241107622988BK960070
3244971271170604BK200476
3244971494908573BK070030
706461699470408BK060062
863241699470408BK060062
706461024076170
706461169353417
706461311739575
706461390765795
706461398622027
706461433270280
706461606004583
706461904429824
706462012705183
706462029885639
706461036022440
863241135715901
3170181138111564
706461220216321
863241252160210
706461252160210
706461267730613
706461269403316
3170181429607468
863241429703561
706461490662218
863241494908573
863241508983017
706461508983017
706461582656107
706461620638138
706461661406678
706461844210074
706461885553142
863241911168323
706461911168323
706461948736219
706461977936825
863241977936825
706461999991738
706462003146203
706462036945900
706462038989086

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJX82011-05-27
ONX22016-05-16
LTK22015-05-21
GMT21997-11-13
SET12025-05-16
QSE12022-05-04
JJY12010-10-05
MKW12006-02-06
GOI11982-04-16

PMN#

54 records. Showing 1-40. Next

GUDID#

101 records. Showing 1-40. Next