Fujirebio Diagnostics Inc

FDA Filings

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

Fujirebio Diagnostics Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Greg Dickson
• Fujirebio Europe N.V.
• Fujirebio Inc.

FDA Registration(s)

• Registration Number: 3000125561
• FEI Number: 3000125561
• Name: Greg Dickson
• Owner & Operator: Fujirebio Diagnostics, Inc.
• Contact Address: 201 Great Valley Parkway ; Malvern PA 19355 US
• Official Correspondent:
  • Greg Dickson
  • x-610-2403888-x
• US Agent:
  • Greg Dickson
  • Fujirebio Diagnostics, Inc.
  • 610 2403888
  • 610 2403820
  • dicksong@fdi.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 201 Great Valley Parkway ; Malvern, PA 19355 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 9615837
• FEI Number: 3002608770
• Name: Fujirebio Europe N.V.
• Owner & Operator: Fujirebio Diagnostics, Inc.
• Contact Address: 201 Great Valley Parkway ; Malvern PA 19355 US
• Official Correspondent:
  • Greg Dickson
  • x-610-2403888-x
• US Agent:
  • Greg Dickson
  • Fujirebio Diagnostics, Inc.
  • 610 2403888
  • 610 2403820
  • dicksong@fdi.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: TECHNOLOGIEPARK 6 ; GHENT Oost-Vlaanderen, B-9052 BE
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 2521625
• FEI Number: 2521625
• Name: Fujirebio Diagnostics, Inc.
• Owner & Operator: Fujirebio Diagnostics, Inc.
• Contact Address: 201 Great Valley Parkway ; Malvern PA 19355 US
• Official Correspondent:
  • Greg Dickson
  • x-610-2403888-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 201 Great Valley Parkway ; Malvern, PA 19355 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only

• Registration Number: 8031611
• FEI Number: 3004083851
• Name: Greg Dickson
• Owner & Operator: Fujirebio Diagnostics, Inc.
• Contact Address: 201 Great Valley Parkway ; Malvern PA 19355 US
• Official Correspondent:
  • Greg Dickson
  • x-610-2403888-x
• US Agent:
  • Greg Dickson
  • Fujirebio Diagnostics, Inc.
  • 610 2403888
  • 610 2403820
  • dicksong@fdi.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 201 Great Valley Parkway ; Malvern, PA 19355 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3002895169
• FEI Number: 3002895169
• Name: Fujirebio Inc.
• Owner & Operator: Fujirebio Diagnostics, Inc.
• Contact Address: 201 Great Valley Parkway ; Malvern PA 19355 US
• Official Correspondent:
  • Greg Dickson
  • x-610-2403888-x
• US Agent:
  • Greg Dickson
  • FUJIREBIO DIAGNOSTICS, INC.
  • 610 2403888
  • 610 2403820
  • dicksong@fdi.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1-3-14 Tanashioda, Chuo-ku ; Sagamihara Kanagawa, 252-0245 JP
• Establishment Type: Manufacture Medical Device

• Registration Number: 1643621
• FEI Number: 1643621
• Name: Fujirebio Diagnostics, Inc.
• Owner & Operator: Fujirebio Diagnostics, Inc.
• Contact Address: 201 Great Valley Parkway ; Malvern PA 19355 US
• Official Correspondent:
  • Greg Dickson
  • x-610-2403888-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 940 Crossroads Blvd ; Seguin, TX 78155 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00869164000086 Fujirebio Diagnostics, Inc.	Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio	2024-11-12
GUDID 00869164000079 FUJIREBIO DIAGNOSTICS, INC.	Emit Cyclosporine Sample	2023-12-14
GUDID 00869164000062 FUJIREBIO DIAGNOSTICS, INC.	Serodia TP-PA Kits	2023-12-14
GUDID 00869164000055 FUJIREBIO DIAGNOSTICS, INC.	Serodia TP-PA Kits	2023-12-14
GUDID 00869164000048 Fujirebio Diagnostics, Inc.	Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator Tool	2022-03-22
PMN K192524 Fujirebio Diagnostics, Inc.	Lumipulse G CA15-3	2020-09-04
PMN K200997 Fujirebio Diagnostics, Inc.	Lumipulse G CA19-9-N	2020-05-14
PMN K190702 | CEW Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G whole PTH Immunoreaction Cartridges	2019-12-18
PMN K190702 | CEW Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G whole PTH Calibrators	2019-12-18
PMN K190702 Fujirebio Diagnostics, Inc.	Lumipulse G Whole PTH	2019-08-30
JJY Greg Dickson [Fujirebio Diagnostics, Inc.]	Mesothelin Control	2019-03-05
JJY Greg Dickson [Fujirebio Diagnostics, Inc.]	Lung Marker Control	2019-03-05
JJY Greg Dickson [Fujirebio Diagnostics, Inc.]	AMH Control	2019-03-05
JJX Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse PTH Controls	2018-12-05
JJX Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse BRAHMS PCT Controls	2018-12-05
JJX Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Alinity i HE4 Controls	2018-12-05
JJX Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Alinity i CA 19-9XR Controls	2018-12-05
JJX Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Alinity i CA 15-3 Controls	2018-12-05
JJX Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Alinity i CA 125II Controls	2018-12-05
JJX Fujirebio Diagnostics, Inc.	Lumipulse PTH Controls	2018-12-05
JJX Fujirebio Diagnostics, Inc.	Lumipulse BRAHMS PCT Controls	2018-12-05
JJX Fujirebio Diagnostics, Inc.	Alinity i HE4 Controls	2018-12-05
JJX Fujirebio Diagnostics, Inc.	Alinity i CA 19-9XR Controls	2018-12-05
JJX Fujirebio Diagnostics, Inc.	Alinity i CA 15-3 Controls	2018-12-05
JJX Fujirebio Diagnostics, Inc.	Alinity i CA 125II Controls	2018-12-05
JIT Fujirebio Diagnostics, Inc.	Alinity i Tacrolimus Calibrators	2018-12-05
JIT Fujirebio Diagnostics, Inc.	Alinity i Sirolimus Calibrators	2018-12-05
JIT Fujirebio Diagnostics, Inc.	Alinity i HE4 Calibrators	2018-12-05
JIT Fujirebio Diagnostics, Inc.	Alinity i CA 19-9XR Calibrators	2018-12-05
JIT Fujirebio Diagnostics, Inc.	Alinity i CA 15-3 Calibrators	2018-12-05
JIT Fujirebio Diagnostics, Inc.	Alinity i CA 125II Calibrators	2018-12-05
MSW Fujirebio Diagnostics, Inc.	ARCHITECT Thyroglobulin Reagents	2018-12-03
MSW Fujirebio Diagnostics, Inc.	ARCHITECT Thyroglobulin Controls	2018-12-03
MSW Fujirebio Diagnostics, Inc.	ARCHITECT Thyroglobulin Calibrators	2018-12-03
GUDID 00869164000024 Fujirebio Diagnostics, Inc.	ROMA	2018-07-06
GUDID 00869164000017 Fujirebio Diagnostics, Inc.	Lumipulse G ROMA	2018-07-06
GUDID 00869164000000 Fujirebio Diagnostics, Inc.	MESOMARK	2018-07-06
PMN K053061 | MKW Fujirebio Diagnostics, Inc.	EMIT 2000 Cyclosporine Specific Assay	2018-06-04
PMN K172713 | PRI Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G BRAHMS PCT Immunoreaction Cartridges	2018-04-02
PMN K172713 | PRI Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G BRAHMS PCT Calibrator Set	2018-04-02
PMN K172713 | PRI Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G BRAHMS PCT Calculator Tool	2018-04-02
PMN K172713 | PMT Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G BRAHMS PCT Immunoreaction Cartridges	2018-04-02
PMN K172713 | PMT Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G BRAHMS PCT Calibrator Set	2018-04-02
PMN K172713 | PMT Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G BRAHMS PCT Calculator Tool	2018-04-02
PMN K172713 | NTM Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G BRAHMS PCT Immunoreaction Cartridges	2018-04-02
PMN K172713 | NTM Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G BRAHMS PCT Calibrator Set	2018-04-02
PMN K172713 | NTM Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G BRAHMS PCT Calculator Tool	2018-04-02
PMN K172713 Fujirebio Diagnostics, Inc.	Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators Set	2017-12-10
PMN K171103 | JLW Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G TSH-III Immunoreaction Cartridges and Calibrators	2017-10-31
PMN K163544 | JIT Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G Prolactin Immunoreaction Cartridges	2017-10-16
PMN K163544 | JIT Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G Prolactin Calibrators	2017-10-16
PMN K163521 | JIT Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G LH Immunoreaction Cartridges	2017-08-31
PMN K163521 | JIT Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G LH Calibrators	2017-08-31
PMN K171103 Fujirebio Diagnostics, Inc.	Lumipulse G TSH-III Immunoreaction Cartridges	2017-07-28
PMN K163534 | JIT Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G FSH-N Immunoreaction Cartridges	2017-07-26
PMN K163534 | JIT Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G FSH-N Calibrators	2017-07-26
MOI Fujirebio Diagnostics, Inc.	Alinity i CA 15-3 Reagent Kit	2017-07-13
MOI Fujirebio Diagnostics, Inc.	Alinity i CA 15-3 Reagent (China)	2017-07-13
MOI Fujirebio Diagnostics, Inc.	Alinity i CA 15-3 Controls	2017-07-13
MOI Fujirebio Diagnostics, Inc.	Alinity i CA 15-3 Calibrators	2017-07-13
MOI Fujirebio Diagnostics, Inc.	Alinity i CA 15-3 Calibrators (China)	2017-07-13
MOI Fujirebio Diagnostics, Inc.	ARCHITECT CA 15-3 Reagents (China)	2017-07-13
MOI Fujirebio Diagnostics, Inc.	ARCHITECT CA 15-3 Calibrators (China)	2017-07-13
OHQ Fujirebio Diagnostics, Inc.	Syphilis Control Set	2017-02-10
PMN K163546 Fujirebio Diagnostics, Inc.	Lumipulse G Progesterone-N Calibrators	2017-01-13
PMN K163534 Fujirebio Diagnostics, Inc.	Lumipulse G FSH-N Calibrators	2017-01-13
PMN K163544 FUJIREBIO DIAGNOSTICS, INC.	Lumipulse G Prolactin	2017-01-12
PMN K163521 FUJIREBIO DIAGNOSTICS, INC	Lumipulse G LH Calibrators	2017-01-12
JJE Fujirebio Europe N.V. [Fujirebio Diagnostics, Inc.]	TENDIGO Cat No. 80412	2016-12-19
PMN K163053 Fujirebio Diagnostics, Inc.	Lumipulse G E2-III Calibrators	2016-12-01
PMN K153145 | LIP Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G TP-N Immunreaction Cartridges Set	2016-07-29
PMN K153361 | MRG Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G 25-OH Vitamin D	2016-07-14
PMN K153361 | MRG Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G 25-OH Vitamin D Calibrators	2016-07-14
PMN K153361 | JIT Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G 25-OH Vitamin D	2016-07-14
PMN K153361 | JIT Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G 25-OH Vitamin D Calibrators	2016-07-14
PMN K153145 Fujirebio Diagnostics, Inc.	Lumipulse G TP-N Immunoreaction Cartridge Set	2016-07-05
PMN K151502 | ONX Fujirebio Diagnostics, Inc.	ARCHITECT ROMA	2016-07-05
PMN K160090 | ONX Fujirebio Diagnostics, Inc.	Lumipulse G ROMA	2016-06-06
PMN K160090 Fujirebio Diagnostics, Inc.	Lumipulse G ROMA	2016-05-16
PMN K151502 Fujirebio Diagnostics, Inc.	ARCHITECT ROMA	2016-04-28
PMN K151378 | OIU Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G HE4 Immunoreaction Cartridges	2016-04-19
PMN K151378 | OIU Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G HE4 Calibrators	2016-04-19
PMN K151378 | JIT Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G HE4 Immunoreaction Cartridges	2016-04-19
PMN K151378 | JIT Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G HE4 Calibrators	2016-04-19
PMN K142895 | LTK Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G CA125II Immunoreaction Cartridges	2016-04-19
PMN K142895 | LTK Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G CA125II Calibrators	2016-04-19
PMN K142895 | LTK Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	LUMIPULSE G1200 System	2016-04-19
PMN K142895 | JJE Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G CA125II Immunoreaction Cartridges	2016-04-19
PMN K142895 | JJE Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G CA125II Calibrators	2016-04-19
PMN K142895 | JJE Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	LUMIPULSE G1200 System	2016-04-19
PMN K142895 | JIT Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G CA125II Immunoreaction Cartridges	2016-04-19
PMN K142895 | JIT Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	Lumipulse G CA125II Calibrators	2016-04-19
PMN K142895 | JIT Fujirebio Inc. [Fujirebio Diagnostics, Inc.]	LUMIPULSE G1200 System	2016-04-19
PMN K153361 FUJIREBIO DIAGNOSTICS, INC.	Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators	2016-04-15
PMN K151378 Fujirebio Diagnostics, Inc.	Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators	2015-11-24
PMN K142895 FUJIREBIO DIAGNOSTICS, INC	LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators	2015-05-21
PMN K140436 | OSX Fujirebio Diagnostics, Inc.	ARCHITECT Galectin-3 Reagents, Calibrators and Controls (US)	2014-12-30
PMN K140436 | JJX Fujirebio Diagnostics, Inc.	ARCHITECT Galectin-3 Reagents, Calibrators and Controls (US)	2014-12-30
PMN K140436 | JIT Fujirebio Diagnostics, Inc.	ARCHITECT Galectin-3 Reagents, Calibrators and Controls (US)	2014-12-30
PMN K140436 FUJIREBIO DIAGNOSTICS, INC.	ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS	2014-12-23
LAO Fujirebio Diagnostics, Inc.	Alinity i Methotrexate Reagent, Calibrators, Controls and Extended Range Controls	2014-11-03
LAO Fujirebio Diagnostics, Inc.	ARCHITECT Methotrexate Reagent, Calibrators, Controls and Extended Range Controls	2014-11-03
KPA Fujirebio Europe N.V. [Fujirebio Diagnostics, Inc.]	Auto LiPA 48 and Auto LIA 48	2014-06-04
OSX Fujirebio Diagnostics, Inc.	Alinity i Galectin-3 Reagents, Calibrators and Controls	2014-02-27
PMN K133197 FUJIREBIO DIAGNOSTICS, INC.	FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE	2014-01-17
PMN K123612 FUJIREBIO DIAGNOSTICS, INC.	FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA	2013-01-17
OVK Fujirebio Diagnostics, Inc.	NSE [For Use With ARCHITECT] Reagent	2013-01-17
OVK Fujirebio Diagnostics, Inc.	NSE [For Use With ARCHITECT] Controls	2013-01-17
OVK Fujirebio Diagnostics, Inc.	NSE [For Use With ARCHITECT] Calibrators	2013-01-17
OVK Fujirebio Diagnostics, Inc.	NSE [FOR USE WITH] Alinity i Reagent	2013-01-17
OVK Fujirebio Diagnostics, Inc.	NSE [FOR USE WITH] Alinity i Controls	2013-01-17
OVK Fujirebio Diagnostics, Inc.	NSE [FOR USE WITH] Alinity i Calibrators	2013-01-17
OVK Fujirebio Diagnostics, Inc.	Alinity i CYFRA 21-1 Reagents	2013-01-17
OVK Fujirebio Diagnostics, Inc.	Alinity i CYFRA 21-1 Controls	2013-01-17
OVK Fujirebio Diagnostics, Inc.	Alinity i CYFRA 21-1 Calibrators	2013-01-17
OVK Fujirebio Diagnostics, Inc.	ARCHITECT CYFRA 21-1 Reagent	2013-01-17
OVK Fujirebio Diagnostics, Inc.	ARCHITECT CYFRA 21-1 Controls	2013-01-17
OVK Fujirebio Diagnostics, Inc.	ARCHITECT CYFRA 21-1 Calibrator	2013-01-17
LTK Fujirebio Diagnostics, Inc.	Alinity i CA 125II Reagents (China)	2012-10-11
LTK Fujirebio Diagnostics, Inc.	Alinity i CA 125II Reagent Kit	2012-10-11
LTK Fujirebio Diagnostics, Inc.	Alinity i CA 125II Controls	2012-10-11
LTK Fujirebio Diagnostics, Inc.	Alinity i CA 125II Calibrators	2012-10-11
LTK Fujirebio Diagnostics, Inc.	Alinity i CA 125II Calibrators (China)	2012-10-11
LTK Fujirebio Diagnostics, Inc.	ARCHITECT CA125II Reagents (China)	2012-10-11
LTK Fujirebio Diagnostics, Inc.	ARCHITECT CA125II ROW with HBR	2012-10-11
LTK Fujirebio Diagnostics, Inc.	ARCHITECT CA125II Calibrators (China)	2012-10-11
OTR Greg Dickson [Fujirebio Diagnostics, Inc.]	Canag NSE EIA Kit	2012-01-19
PMN K103358 | ONX Fujirebio Diagnostics, Inc.	ROMA (HE4 EIA + ARCHITECT CA 125 II)	2011-10-24
PMN K103358 FUJIREBIO DIAGNOSTICS, INC.	ROMA (HE4 EIA + ARCHITECT CA 125 II)	2011-09-01
PMN K103676 FUJIREBIO DIAGNOSTICS, INC.	FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL	2011-07-19
PMN K110436 | JJX Fujirebio Diagnostics, Inc.	FDI Glucose Control Solution for Aviva	2011-06-13
OAW Fujirebio Diagnostics, Inc.	MESOMARK - ROW	2011-06-13
PMN K110641 | JJX Fujirebio Diagnostics, Inc.	Fujirebio Diagnostics Vitamin D Control	2011-06-06
PMN K100831 | OVK Greg Dickson [Fujirebio Diagnostics, Inc.]	CYFRA EIA	2011-06-06
PMN K110641 FUJIREBIO DIAGNOSTICS, INC	FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL	2011-05-27
PMN K100831 FUJIREBIO DIAGNOSTICS, INC	CYFRA 21-1 EIA MODEL 211-10	2011-05-26
PMN K110436 FUJIREBIO DIAGNOSTICS, INC	FDI GLUCOSE CONTROL SOLUTION FOR AVIVA	2011-04-20
PMN K103450 FUJIREBIO DIAGNOSTICS, INC	FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE	2011-01-25
PMN K101809 | JJY Greg Dickson [Fujirebio Diagnostics, Inc.]	Fujirebio Diagnostics Tumor Marker Control	2010-12-02
PMN K101809 FUJIREBIO DIAGNOSTICS, INC	FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20	2010-10-05
PMN K102260 FUJIREBIO DIAGNOSTICS, INC	FDI GLUCOSE CONTROL SOLUTIONS	2010-09-24
PMN K093957 | OIU Fujirebio Diagnostics, Inc.	Alinity i HE4	2010-03-23
PMN K093957 | OIU Fujirebio Diagnostics, Inc.	ARCHITECT HE4	2010-03-23
PMN K093957 | JJX Fujirebio Diagnostics, Inc.	Alinity i HE4	2010-03-23
PMN K093957 | JJX Fujirebio Diagnostics, Inc.	ARCHITECT HE4	2010-03-23
PMN K093957 | JIT Fujirebio Diagnostics, Inc.	Alinity i HE4	2010-03-23
PMN K093957 | JIT Fujirebio Diagnostics, Inc.	ARCHITECT HE4	2010-03-23
PMN K093957 FUJIREBIO DIAGNOSTICS, INC	ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,	2010-03-18
OIU Fujirebio Diagnostics, Inc.	Alinity i HE4 Reagents (China)	2010-02-03
OIU Fujirebio Diagnostics, Inc.	Alinity i HE4 Reagent Kit	2010-02-03
OIU Fujirebio Diagnostics, Inc.	Alinity i HE4 Controls	2010-02-03
OIU Fujirebio Diagnostics, Inc.	Alinity i HE4 Controls (China)	2010-02-03
OIU Fujirebio Diagnostics, Inc.	Alinity i HE4 Calibrators	2010-02-03
OIU Fujirebio Diagnostics, Inc.	Alinity i HE4 Calibrators (China)	2010-02-03
OIU Fujirebio Diagnostics, Inc.	ARCHITECT HE4 Reagents (China)	2010-02-03
OIU Fujirebio Diagnostics, Inc.	ARCHITECT HE4 Controls (China)	2010-02-03
OIU Fujirebio Diagnostics, Inc.	ARCHITECT HE4 Calibrators (China)	2010-02-03
OIU Fujirebio Diagnostics, Inc.	ARCHITECT HE4 -ROW	2010-02-03
PMN K083549 | JJX Fujirebio Diagnostics, Inc.	Glucose Control Solution for FreeStyle and FreeStyle Lite	2008-12-23
PMN K080751 | MKW Fujirebio Diagnostics, Inc.	Transplant Pretreatment Tubes 1P06	2008-11-17
PMN K080751 | MKW Fujirebio Diagnostics, Inc.	Transplant Pretreatment Tubes 1P06	2008-11-17
PMN K080751 | MKW Fujirebio Diagnostics, Inc.	ARCHITECT Cyclosporine	2008-11-17
PMN K080751 | MKW Fujirebio Diagnostics, Inc.	ARCHITECT Cyclosporine	2008-11-17
PMN K080751 | MKW Fujirebio Diagnostics, Inc.	ARCHITECT Cyclosporine Whole Blood Precipitation Reagent	2008-11-17
PMN K080751 | MKW Fujirebio Diagnostics, Inc.	ARCHITECT Cyclosporine Whole Blood Precipitation Reagent	2008-11-17
PMN K080751 | DLJ Fujirebio Diagnostics, Inc.	Transplant Pretreatment Tubes 1P06	2008-11-17
PMN K080751 | DLJ Fujirebio Diagnostics, Inc.	Transplant Pretreatment Tubes 1P06	2008-11-17
PMN K080751 | DLJ Fujirebio Diagnostics, Inc.	ARCHITECT Cyclosporine	2008-11-17
PMN K080751 | DLJ Fujirebio Diagnostics, Inc.	ARCHITECT Cyclosporine	2008-11-17
PMN K080751 | DLJ Fujirebio Diagnostics, Inc.	ARCHITECT Cyclosporine Whole Blood Precipitation Reagent	2008-11-17
PMN K080751 | DLJ Fujirebio Diagnostics, Inc.	ARCHITECT Cyclosporine Whole Blood Precipitation Reagent	2008-11-17
PMN K080751 FUJIREBIO DIAGNOSTICS, INC.	ARCHITECT CYCLOSPORINE	2008-09-11
PMN K080273 | JJX Fujirebio Diagnostics, Inc.	Liberty Normal Control (Breeze 2)	2008-08-19
NIG Fujirebio Diagnostics, Inc.	Alinity i CA 19-9XR Reagents (China)	2008-07-07
NIG Fujirebio Diagnostics, Inc.	Alinity i CA 19-9XR Reagent Kit	2008-07-07
NIG Fujirebio Diagnostics, Inc.	Alinity i CA 19-9XR Controls	2008-07-07
NIG Fujirebio Diagnostics, Inc.	Alinity i CA 19-9XR Calibrators	2008-07-07
NIG Fujirebio Diagnostics, Inc.	Alinity i CA 19-9XR Calibrators (China)	2008-07-07
NIG Fujirebio Diagnostics, Inc.	ARCHITECT CA 19-9XR Reagents (China)	2008-07-07
NIG Fujirebio Diagnostics, Inc.	ARCHITECT CA 19-9XR Calibrators (China)	2008-07-07
NIG Fujirebio Diagnostics, Inc.	ARCHITECT CA 19-9XR (ROW)	2008-07-07
NIG Fujirebio Diagnostics, Inc.	ARCHITECT CA 19-9XR (Japan Only)	2008-07-07
NBC Fujirebio Diagnostics, Inc.	Alinity i BNP-JP Reagents, Calibrators and Controls	2008-07-07
NBC Fujirebio Diagnostics, Inc.	Alinity i BNP Reagents, Calibrators and Controls (China)	2008-07-07
NBC Fujirebio Diagnostics, Inc.	Alinity i BNP Reagent Kit	2008-07-07
NBC Fujirebio Diagnostics, Inc.	Alinity i BNP Controls	2008-07-07
NBC Fujirebio Diagnostics, Inc.	Alinity i BNP Calibrators	2008-07-07
NBC Fujirebio Diagnostics, Inc.	ARCHITECT BNP-JP Reagent, Calibrators and Controls	2008-07-07
NBC Fujirebio Diagnostics, Inc.	ARCHITECT BNP Reagents, Calibrators and Controls	2008-07-07
NBC Fujirebio Diagnostics, Inc.	ARCHITECT BNP Reagents, Calibrators and Controls (China)	2008-07-07
PMN K072939 | OIU Greg Dickson [Fujirebio Diagnostics, Inc.]	HE4 EIA	2008-06-12
PMN K072939 FUJIREBIO DIAGNOSTICS, INC.	HE4 EIA, MODEL: 404-10 US	2008-06-09
PMN K070649 | JJX Fujirebio Diagnostics, Inc.	Glucose Control Solution for TrackEASE and TrueTrack	2008-06-02
PMN K063855 | JJX Fujirebio Diagnostics, Inc.	Liberty Normal Glucose Control Solution	2008-06-02
PMN K060481 | JJX Fujirebio Diagnostics, Inc.	Liberty Glucose Control (TheraSense)	2008-06-02
PMN K060426 | JJX Fujirebio Diagnostics, Inc.	Liberty's Glucose Normal Control Solution	2008-06-02
PMN BK960092 | KSZ Greg Dickson [Fujirebio Diagnostics, Inc.]	Beckman Coulter PK CMV Test System	2008-05-30
PMN BK960092 | KSZ Fujirebio Diagnostics, Inc.	Beckman Coulter PK CMV Test System	2008-05-30
PMN BK960070 | KSF Fujirebio Diagnostics, Inc.	Beckman Coulter PK TP System Control Set	2008-05-30
PMN BK960070 | KSF Fujirebio Diagnostics, Inc.	Beckman Coulter PK TP System Control Set	2008-05-30
PMN BK070030 | KSZ Greg Dickson [Fujirebio Diagnostics, Inc.]	Beckman Coulter PK CMV Test System	2008-05-30
PMN BK070030 | KSZ Fujirebio Diagnostics, Inc.	Beckman Coulter PK CMV Test System	2008-05-30
PMN BK060062 | KSZ Greg Dickson [Fujirebio Diagnostics, Inc.]	Beckman Coulter PK TP Reagent System	2008-05-30
PMN BK060062 | KSZ Fujirebio Diagnostics, Inc.	Beckman Coulter PK TP Reagent System	2008-05-30
PMN BK060062 | KSZ Fujirebio Diagnostics, Inc.	Beckman Coulter PK TP Reagent System	2008-05-30
PMN BK030007 | MYR Greg Dickson [Fujirebio Diagnostics, Inc.]	Beckman Coulter PK TP System	2008-05-30
PMN K990783 | JJX Fujirebio Diagnostics, Inc.	VITROS CA15-3	2007-10-17
PMN K984289 | LTJ Fujirebio Diagnostics, Inc.	VITROS PSA	2007-10-17
PMN K983875 | LTK Fujirebio Diagnostics, Inc.	VITROS CA125II	2007-10-17
PMN K983690 | MOI Fujirebio Diagnostics, Inc.	VITROS CA15-3 Reagent	2007-10-17
PMN K971502 | GMT Greg Dickson [Fujirebio Diagnostics, Inc.]	Serodia TP-PA	2007-10-17
PMN K820499 | GOI Fujirebio Diagnostics, Inc.	FITC Anti-Rabies Monoclonal Globulin	2007-10-17
PMN K070822 | NRP Fujirebio Diagnostics, Inc.	Transplant Pretreatment Tubes 1P06	2007-10-17
PMN K070822 | NRP Fujirebio Diagnostics, Inc.	Transplant Pretreatment Tubes 1P06	2007-10-17
PMN K070822 | NRP Fujirebio Diagnostics, Inc.	Alinity i Sirolimus Whole Blood Precipitation Reagent	2007-10-17
PMN K070822 | NRP Fujirebio Diagnostics, Inc.	Alinity i Sirolimus Whole Blood Precipitation Reagent	2007-10-17
PMN K070822 | NRP Fujirebio Diagnostics, Inc.	Alinity i Sirolimus Reagent Kit	2007-10-17
PMN K070822 | NRP Fujirebio Diagnostics, Inc.	Alinity i Sirolimus Reagent Kit	2007-10-17
PMN K070822 | NRP Fujirebio Diagnostics, Inc.	ARCHITECT Sirolimus	2007-10-17
PMN K070822 | NRP Fujirebio Diagnostics, Inc.	ARCHITECT Sirolimus	2007-10-17
PMN K070822 | NRP Fujirebio Diagnostics, Inc.	ARCHITECT Sirolimus Whole Blood Precipitation Reagent	2007-10-17
PMN K070822 | NRP Fujirebio Diagnostics, Inc.	ARCHITECT Sirolimus Whole Blood Precipitation Reagent	2007-10-17
PMN K070822 | JIT Fujirebio Diagnostics, Inc.	Transplant Pretreatment Tubes 1P06	2007-10-17
PMN K070822 | JIT Fujirebio Diagnostics, Inc.	Transplant Pretreatment Tubes 1P06	2007-10-17
PMN K070822 | JIT Fujirebio Diagnostics, Inc.	Alinity i Sirolimus Whole Blood Precipitation Reagent	2007-10-17
PMN K070822 | JIT Fujirebio Diagnostics, Inc.	Alinity i Sirolimus Whole Blood Precipitation Reagent	2007-10-17
PMN K070822 | JIT Fujirebio Diagnostics, Inc.	Alinity i Sirolimus Reagent Kit	2007-10-17
PMN K070822 | JIT Fujirebio Diagnostics, Inc.	Alinity i Sirolimus Reagent Kit	2007-10-17
PMN K070822 | JIT Fujirebio Diagnostics, Inc.	ARCHITECT Sirolimus	2007-10-17
PMN K070822 | JIT Fujirebio Diagnostics, Inc.	ARCHITECT Sirolimus	2007-10-17
PMN K070822 | JIT Fujirebio Diagnostics, Inc.	ARCHITECT Sirolimus Whole Blood Precipitation Reagent	2007-10-17
PMN K070822 | JIT Fujirebio Diagnostics, Inc.	ARCHITECT Sirolimus Whole Blood Precipitation Reagent	2007-10-17
PMN K070820 | MLM Fujirebio Diagnostics, Inc.	Transplant Pretreatment Tubes 1P06	2007-10-17
PMN K070820 | MLM Fujirebio Diagnostics, Inc.	Transplant Pretreatment Tubes 1P06	2007-10-17
PMN K070820 | MLM Fujirebio Diagnostics, Inc.	Alinity i Tacrolimus Whole Blood Precipitation Reagent	2007-10-17
PMN K070820 | MLM Fujirebio Diagnostics, Inc.	Alinity i Tacrolimus Whole Blood Precipitation Reagent	2007-10-17
PMN K070820 | MLM Fujirebio Diagnostics, Inc.	Alinity i Tacrolimus Reagent	2007-10-17
PMN K070820 | MLM Fujirebio Diagnostics, Inc.	Alinity i Tacrolimus Reagent	2007-10-17
PMN K070820 | MLM Fujirebio Diagnostics, Inc.	ARCHITECT Tacrolimus	2007-10-17
PMN K070820 | MLM Fujirebio Diagnostics, Inc.	ARCHITECT Tacrolimus	2007-10-17
PMN K070820 | MLM Fujirebio Diagnostics, Inc.	ARCHITECT Tacrolimus Whole Blood Precipitation Reagent	2007-10-17
PMN K070820 | MLM Fujirebio Diagnostics, Inc.	ARCHITECT Tacrolimus Whole Blood Precipitation Reagent	2007-10-17
PMN K070820 | MLM Fujirebio Diagnostics, Inc.	ARCHITECT Tacrolimus Calibrators	2007-10-17
PMN K070820 | MLM Fujirebio Diagnostics, Inc.	ARCHITECT Tacrolimus Calibrators	2007-10-17
PMN K070820 | JIT Fujirebio Diagnostics, Inc.	Transplant Pretreatment Tubes 1P06	2007-10-17
PMN K070820 | JIT Fujirebio Diagnostics, Inc.	Transplant Pretreatment Tubes 1P06	2007-10-17
PMN K070820 | JIT Fujirebio Diagnostics, Inc.	Alinity i Tacrolimus Whole Blood Precipitation Reagent	2007-10-17
PMN K070820 | JIT Fujirebio Diagnostics, Inc.	Alinity i Tacrolimus Whole Blood Precipitation Reagent	2007-10-17
PMN K070820 | JIT Fujirebio Diagnostics, Inc.	Alinity i Tacrolimus Reagent	2007-10-17
PMN K070820 | JIT Fujirebio Diagnostics, Inc.	Alinity i Tacrolimus Reagent	2007-10-17
PMN K070820 | JIT Fujirebio Diagnostics, Inc.	ARCHITECT Tacrolimus	2007-10-17
PMN K070820 | JIT Fujirebio Diagnostics, Inc.	ARCHITECT Tacrolimus	2007-10-17
PMN K070820 | JIT Fujirebio Diagnostics, Inc.	ARCHITECT Tacrolimus Whole Blood Precipitation Reagent	2007-10-17
PMN K070820 | JIT Fujirebio Diagnostics, Inc.	ARCHITECT Tacrolimus Whole Blood Precipitation Reagent	2007-10-17
PMN K070820 | JIT Fujirebio Diagnostics, Inc.	ARCHITECT Tacrolimus Calibrators	2007-10-17
PMN K070820 | JIT Fujirebio Diagnostics, Inc.	ARCHITECT Tacrolimus Calibrators	2007-10-17
PMN K060964 | NBC Fujirebio Diagnostics, Inc.	ARCHITECT BNP	2007-10-17
PMN K060964 | JJX Fujirebio Diagnostics, Inc.	ARCHITECT BNP	2007-10-17
PMN K060964 | JIT Fujirebio Diagnostics, Inc.	ARCHITECT BNP	2007-10-17
PMN K052889 | NIG Fujirebio Diagnostics, Inc.	VITROS CA 19-9	2007-10-17
PMN K052889 | JJX Fujirebio Diagnostics, Inc.	VITROS CA 19-9	2007-10-17
PMN K052889 | JIT Fujirebio Diagnostics, Inc.	VITROS CA 19-9	2007-10-17
PMN K052000 | NIG Fujirebio Diagnostics, Inc.	Alinity i CA 19-9XR	2007-10-17
PMN K052000 | NIG Fujirebio Diagnostics, Inc.	ARCHITECT CA 19-9XR	2007-10-17
PMN K052000 | JJX Fujirebio Diagnostics, Inc.	Alinity i CA 19-9XR	2007-10-17
PMN K052000 | JJX Fujirebio Diagnostics, Inc.	ARCHITECT CA 19-9XR	2007-10-17
PMN K052000 | JIT Fujirebio Diagnostics, Inc.	Alinity i CA 19-9XR	2007-10-17
PMN K052000 | JIT Fujirebio Diagnostics, Inc.	ARCHITECT CA 19-9XR	2007-10-17
PMN K042732 | MOI Fujirebio Diagnostics, Inc.	Alinity i CA 15-3	2007-10-17
PMN K042732 | MOI Fujirebio Diagnostics, Inc.	ARCHITECT CA 15-3	2007-10-17
PMN K042732 | JJX Fujirebio Diagnostics, Inc.	Alinity i CA 15-3	2007-10-17
PMN K042732 | JJX Fujirebio Diagnostics, Inc.	ARCHITECT CA 15-3	2007-10-17
PMN K042732 | JIT Fujirebio Diagnostics, Inc.	Alinity i CA 15-3	2007-10-17
PMN K042732 | JIT Fujirebio Diagnostics, Inc.	ARCHITECT CA 15-3	2007-10-17
PMN K042731 | LTK Fujirebio Diagnostics, Inc.	Alinity i CA 125II	2007-10-17
PMN K042731 | LTK Fujirebio Diagnostics, Inc.	ARCHITECT CA 125II	2007-10-17
PMN K042731 | JJX Fujirebio Diagnostics, Inc.	Alinity i CA 125II	2007-10-17
PMN K042731 | JJX Fujirebio Diagnostics, Inc.	ARCHITECT CA 125II	2007-10-17
PMN K042731 | JIT Fujirebio Diagnostics, Inc.	Alinity i CA 125II	2007-10-17
PMN K042731 | JIT Fujirebio Diagnostics, Inc.	ARCHITECT CA 125II	2007-10-17
PMN H060004 | OAW Fujirebio Diagnostics, Inc.	MESOMARK	2007-10-17
MVU Fujirebio Europe N.V. [Fujirebio Diagnostics, Inc.]	PROBE ARRAYS HCV 5' UTR ASR	2007-10-17
MVU Fujirebio Europe N.V. [Fujirebio Diagnostics, Inc.]	HCV Enzyme Mix (83L-IB)	2007-10-17
PMN K070822 FUJIREBIO DIAGNOSTICS, INC.	ARCHITECT SIROLIMUS ASSAY	2007-09-28
PMN BK070030 Fujirebio Diagnostics, Inc.	Automated Blood Grouping And Antibody Test Systems	2007-09-20
PMN K070820 FUJIREBIO DIAGNOSTICS, INC.	ARCHITECT TACROLIMUS: MODEL 1L77	2007-08-01
PMN BK060062 Fujirebio Diagnostics, Inc.	Automated Blood Grouping And Antibody Test Systems	2007-06-25
PMN K060964 FUJIREBIO DIAGNOSTICS, INC.	ARCHITECT BNP ASSAY, MODEL 8K28	2006-05-25
PMN K052889 FUJIREBIO DIAGNOSTICS, INC.	VITROS CA 19-9	2005-12-20
PMN K052000 FUJIREBIO DIAGNOSTICS, INC.	ARCHITECT CA 19-9XR ASSAY	2005-10-25
PMN K042732 FUJIREBIO DIAGNOSTICS, INC.	ARCHITECT CA 15-3 ASSAY	2004-12-22
PMN K042731 FUJIREBIO DIAGNOSTICS, INC.	ARCHITECT CA 125 II ASSAY	2004-11-19
PMN K033731 FUJIREBIO DIAGNOSTICS, INC.	AXSYM CORTISOL ASSAY	2004-02-20
PMN BK030007 Fujirebio Diagnostics, Inc.	Test, Syphilis, Treponema (FOR DONOR TESTING)	2003-02-21
PMN K020566 FUJIREBIO DIAGNOSTICS, INC.	FUJIREBIO DIAGNOSTICS CA 19-9 RIA	2002-05-09
PMN BK960070 Fujirebio Diagnostics, Inc	Quality Control Kits For Blood Banking Reagents	1997-06-19
PMN K893124 FUJIREBIO DIAGNOSTICS, INC.	OLYMPUS PK(TM) TP	1989-11-17

Similar & Related FDA Registered Companies

• FUJIREBIO DIAGNOSTICS TEXAS, INC.
• Fujirebio Diagnostics, Inc. TX

Related Finance Registrations

NCAGE Code	1U5D9	FUJIREBIO DIAGNOSTICS, INC.
CAGE Code	1U5D9	FUJIREBIO DIAGNOSTICS, INC.
S.A.M. Registration	1U5D9 [48524263]	FUJIREBIO DIAGNOSTICS, INC.
DUNS	048524263	Fujirebio Diagnostics, Inc.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020061369973	London,United Kingdom -> New York, New York	8 PALLETS CARTONS, BOXES CASES CORRUGATED PAPER & PAPERBOARD	8 PCS
2019040524744	Kobe,Japan -> Los Angeles, California	CARBOYS, BOTTLES, FLASKS & SIMILAR ITEMS, PLA STIC	71 CTN
2019040228340	Kobe,Japan -> Los Angeles, California	CARBOYS, BOTTLES, FLASKS & SIMILAR ITEMS, PLA STIC	71 CTN
2019040137637	Kobe,Japan -> Los Angeles, California	CARBOYS, BOTTLES, FLASKS & SIMILAR ITEMS, PLA STIC	71 CTN