Fujirebio Inc

FDA Filings

This page includes the latest FDA filings for Fujirebio Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3002895169
FEI Number3002895169
NameFujirebio Inc.
Owner & OperatorFujirebio Diagnostics, Inc.
Contact Address201 Great Valley Parkway
Malvern PA 19355 US
Official Correspondent
  • Greg Dickson
  • x-610-2403888-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1-3-14 Tanashioda, Chuo-ku
Sagamihara Kanagawa, 252-0245 JP
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
FUJIREBIO INC.
 Lumipulse Infectious Disease Controls 2025-08-08
FUJIREBIO INC.
 Lumipulse G B-Amyloid Controls (Plasma)-N 2025-01-14
FUJIREBIO INC.
 Lumipulse G B-Amyloid 1-42-N Plasma Calibrator 2025-01-14
FUJIREBIO INC.
 Lumipulse G B-Amyloid 1-42-N Plasma 2025-01-14
FUJIREBIO INC.
 Lumipulse BRAHMS PCT Controls 2023-05-04
FUJIREBIO INC.
 Lumipulse G BRAHMS PCT Calibrator Set 2023-05-04
FUJIREBIO INC.
 Lumipulse B-Amyloid Controls 2022-11-08
FUJIREBIO INC.
 Lumipulse G B-Amyloid 1-40 Calibrator Set 2022-11-08
FUJIREBIO INC.
 Lumipulse G B-Amyloid 1-42 Immunoreaction Calibrator Set 2022-11-08
FUJIREBIO INC.
 Lumipulse G SARS-CoV-2 Ag Immunoreaction Cartridges 2022-03-22
FUJIREBIO INC.
 Lumipulse SARS-CoV-2 Ag Controls 2022-03-22
FUJIREBIO INC.
 Lumipulse G SARS-CoV-2 Ag Calibrator Set 2022-03-22
FUJIREBIO INC.
 Lumipulse G B-Amyloid 1-40 Immunoreaction Cartridges 2022-03-22
FUJIREBIO INC.
 Lumipulse B-Amyloid Controls 2022-03-22
FUJIREBIO INC.
 Lumipulse G B-Amyloid 1-40 Calibrator Set 2022-03-22
FUJIREBIO INC.
 Lumipulse G B-Amyloid 1-42 Immunoreaction Cartridges 2022-03-22
FUJIREBIO INC.
 Lumipulse G B-Amyloid 1-42 Immunoreaction Calibrator Set 2022-03-22
FUJIREBIO INC.
 Lumipulse G Wash Solution 2020-02-07
FUJIREBIO INC.
 Soda Lime for LUMIPULSE System 2020-01-20
FUJIREBIO INC.
 Lumipulse BRAHMS PCT Controls 2020-01-09
FUJIREBIO INC.
 Lumipulse PTH Controls 2020-01-09
FUJIREBIO INC.
 LUMIPULSE G1200 2020-01-06
FUJIREBIO INC.
 Lumipulse G Dilution Cartridges 2020-01-06
FUJIREBIO INC.
 Lumipulse G Whole PTH Calibrators 2019-12-26
FUJIREBIO INC.
 Lumipulse G whole PTH Immunoreaction Cartridges 2019-12-26
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G whole PTH Immunoreaction Cartridges2019-12-18
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G whole PTH Calibrators2019-12-18
FUJIREBIO INC.
 Lumipulse G Testosterone Immunoreaction Cartridges 2019-11-12
FUJIREBIO INC.
 Lumipulse G BHCG Immunoreaction Cartridges 2019-11-12
FUJIREBIO INC.
 Lumipulse G Mesothelin Immunoreaction Cartridges 2019-11-12
FUJIREBIO INC.
 Lumipulse G CA 19-9-N Immunoreaction Cartridges 2019-11-12
FUJIREBIO INC.
 Lumipulse G CA 15-3 Immunoreaction Cartridges 2019-11-12
FUJIREBIO INC.
 Lumipulse G Specimen Diluent 6 2019-11-12
FUJIREBIO INC.
 Lumipulse G Mesothelin Calibrator 2019-11-12
FUJIREBIO INC.
 Lumipulse G BHCG Calibrators 2019-11-12
FUJIREBIO INC.
 Lumipulse G Specimen Diluent 2 2019-11-12
FUJIREBIO INC.
 Lumipulse G Specimen Diluent 3 2019-11-12
FUJIREBIO INC.
 Lumipulse G Testosterone Calibrators 2019-11-12
FUJIREBIO INC.
 Lumipulse G CA 19-9-N Calibrators 2019-11-12
FUJIREBIO INC.
 Lumipulse G CA 15-3 Calibrators 2019-11-12
FUJIREBIO INC.
 Lumipulse G Substrate Solution 2019-03-11
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse PTH Controls2018-12-05
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse BRAHMS PCT Controls2018-12-05
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Alinity i HE4 Controls2018-12-05
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Alinity i CA 19-9XR Controls2018-12-05
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Alinity i CA 15-3 Controls2018-12-05
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Alinity i CA 125II Controls2018-12-05
FUJIREBIO INC.
 Lumipulse G Progesterone-N Immunoreaction Cartridg 2018-10-19
FUJIREBIO INC.
 Lumipulse G E2-III Immunoreaction Cartridges 2018-10-19
FUJIREBIO INC.
 Lumipulse G E2-III Calibrators 2018-10-19
FUJIREBIO INC.
 Lumipulse G Progesterone-N Calibrators 2018-10-19
FUJIREBIO INC.
 Lumipulse G LH Immunoreaction Cartridges 2018-07-06
FUJIREBIO INC.
 Lumipulse G FSH-N Immunoreaction Cartridges 2018-07-06
FUJIREBIO INC.
 Lumipulse G Prolactin Immunoreaction Cartridges 2018-07-06
FUJIREBIO INC.
 Lumipulse G 25-OH Vitamin D Immunoreaction Cartrid 2018-07-06
FUJIREBIO INC.
 Lumipulse G BRAHMS PCT Immunoreaction Cartridges 2018-07-06
FUJIREBIO INC.
 Lumipulse G TP-N Immunoreaction Cartridges Set 2018-07-06
FUJIREBIO INC.
 Lumipulse G CA125II Immunoreaction Cartridges 2018-07-06
FUJIREBIO INC.
 Lumipulse G HE4 Calibrators 2018-07-06
FUJIREBIO INC.
 Lumipulse G HE4 Immunoreaction Cartridges 2018-07-06
FUJIREBIO INC.
 Lumipulse G BRAHMS PCT Calibrator Set 2018-07-06
FUJIREBIO INC.
 Lumipulse G 25-OH Vitamin D Calibrators 2018-07-06
FUJIREBIO INC.
 Lumipulse G Specimen Diluent 1 2018-07-06
FUJIREBIO INC.
 Lumipulse G FSH-N Calibrators 2018-07-06
FUJIREBIO INC.
 Lumipulse G LH Calibrators 2018-07-06
FUJIREBIO INC.
 Lumipulse G CA125II Calibrators 2018-07-06
FUJIREBIO INC.
 Beckman Coulter PK CMV-PA System PA23002018-07-06
FUJIREBIO INC.
 Beckman Coulter PK TP System PH30002018-07-06
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G BRAHMS PCT Immunoreaction Cartridges2018-04-02
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G BRAHMS PCT Calibrator Set2018-04-02
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G BRAHMS PCT Calculator Tool2018-04-02
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G BRAHMS PCT Immunoreaction Cartridges2018-04-02
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G BRAHMS PCT Calibrator Set2018-04-02
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G BRAHMS PCT Calculator Tool2018-04-02
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G BRAHMS PCT Immunoreaction Cartridges2018-04-02
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G BRAHMS PCT Calibrator Set2018-04-02
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G BRAHMS PCT Calculator Tool2018-04-02
FUJIREBIO INC.
 Lumipulse G TSH-III Immunoreaction Cartridges 2018-03-29
FUJIREBIO INC.
 Lumipulse G TSH-III Calibrators 2018-03-29
FUJIREBIO INC.
 Lumipulse G Prolactin Calibrators 2018-03-29
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G TSH-III Immunoreaction Cartridges and Calibrators2017-10-31
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G Prolactin Immunoreaction Cartridges2017-10-16
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G Prolactin Calibrators2017-10-16
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G LH Immunoreaction Cartridges2017-08-31
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G LH Calibrators2017-08-31
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G FSH-N Immunoreaction Cartridges2017-07-26
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G FSH-N Calibrators2017-07-26
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G TP-N Immunreaction Cartridges Set2016-07-29
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G 25-OH Vitamin D2016-07-14
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G 25-OH Vitamin D Calibrators2016-07-14
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G 25-OH Vitamin D2016-07-14
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G 25-OH Vitamin D Calibrators2016-07-14
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G HE4 Immunoreaction Cartridges2016-04-19
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G HE4 Calibrators2016-04-19
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G HE4 Immunoreaction Cartridges2016-04-19
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G HE4 Calibrators2016-04-19
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G CA125II Immunoreaction Cartridges2016-04-19
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G CA125II Calibrators2016-04-19
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
LUMIPULSE G1200 System2016-04-19
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G CA125II Immunoreaction Cartridges2016-04-19
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G CA125II Calibrators2016-04-19
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
LUMIPULSE G1200 System2016-04-19
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G CA125II Immunoreaction Cartridges2016-04-19
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
Lumipulse G CA125II Calibrators2016-04-19
Fujirebio Inc. [Fujirebio Diagnostics, Inc.]
LUMIPULSE G1200 System2016-04-19
Fujirebio, Inc.
Quality Control Kits For Blood Banking Reagents1995-11-29

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Related Finance Registrations
NCAGE CodeSJE25FUJIREBIO INC.
CAGE CodeSJE25FUJIREBIO INC.
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020062521269Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New JerseyINSTRUMENT & APPLIANCE FOR MEDICAL SURGICAL6 CAS
2019041918088Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New JerseyINSTRUMENT & APPLIANCE FOR MEDICAL SURGICAL6 CAS
201804049941Pusan,South Korea -> Houston, TexasPLASTIC BOXES, CASES AND CRATES50 CTN
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