Fujirebio Diagnostics, Inc.

FDA Registration(s)#

GUDID Contact Samples#

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

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Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• Lumipulse G CA15-3

  2020-09-04

  Fujirebio Diagnostics, Inc.

• Lumipulse G CA19-9-N

  2020-05-14

  Fujirebio Diagnostics, Inc.

• Lumipulse G Whole PTH

  2019-08-30

  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

  Fujirebio Diagnostics, Inc.

• Lumipulse G TSH-III Immunoreaction Cartridges

  2017-07-28

  Fujirebio Diagnostics, Inc.

• Lumipulse G Progesterone-N Calibrators

  2017-01-13

  Fujirebio Diagnostics, Inc.

• Lumipulse G FSH-N Calibrators

  2017-01-13

  Fujirebio Diagnostics, Inc.

• Lumipulse G Prolactin

  2017-01-12

  FUJIREBIO DIAGNOSTICS, INC.

• Lumipulse G E2-III Calibrators

  2016-12-01

  Fujirebio Diagnostics, Inc.

• Lumipulse G TP-N Immunoreaction Cartridge Set

  2016-07-05

  Fujirebio Diagnostics, Inc.

• Lumipulse G ROMA

  2016-05-16

  Fujirebio Diagnostics, Inc.

• ARCHITECT ROMA

  2016-04-28

  Fujirebio Diagnostics, Inc.

• Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators

  2016-04-15

  FUJIREBIO DIAGNOSTICS, INC.

• Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators

  2015-11-24

  Fujirebio Diagnostics, Inc.

• ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS

  2014-12-23

  FUJIREBIO DIAGNOSTICS, INC.

• FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE

  2014-01-17

  FUJIREBIO DIAGNOSTICS, INC.

• FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA

  2013-01-17

  FUJIREBIO DIAGNOSTICS, INC.

• ROMA (HE4 EIA + ARCHITECT CA 125 II)

  2011-09-01

  FUJIREBIO DIAGNOSTICS, INC.

• FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL

  2011-07-19

  FUJIREBIO DIAGNOSTICS, INC.

• ARCHITECT CYCLOSPORINE

  2008-09-11

  FUJIREBIO DIAGNOSTICS, INC.

• HE4 EIA, MODEL: 404-10 US

  2008-06-09

  FUJIREBIO DIAGNOSTICS, INC.

• ARCHITECT SIROLIMUS ASSAY

  2007-09-28

  FUJIREBIO DIAGNOSTICS, INC.

• Automated Blood Grouping And Antibody Test Systems

  2007-09-20

  Fujirebio Diagnostics, Inc.

• ARCHITECT TACROLIMUS: MODEL 1L77

  2007-08-01

  FUJIREBIO DIAGNOSTICS, INC.

• Automated Blood Grouping And Antibody Test Systems

  2007-06-25

  Fujirebio Diagnostics, Inc.

• ARCHITECT BNP ASSAY, MODEL 8K28

  2006-05-25

  FUJIREBIO DIAGNOSTICS, INC.

• VITROS CA 19-9

  2005-12-20

  FUJIREBIO DIAGNOSTICS, INC.

• ARCHITECT CA 19-9XR ASSAY

  2005-10-25

  FUJIREBIO DIAGNOSTICS, INC.

• ARCHITECT CA 15-3 ASSAY

  2004-12-22

  FUJIREBIO DIAGNOSTICS, INC.

• ARCHITECT CA 125 II ASSAY

  2004-11-19

  FUJIREBIO DIAGNOSTICS, INC.

• AXSYM CORTISOL ASSAY

  2004-02-20

  FUJIREBIO DIAGNOSTICS, INC.

• Test, Syphilis, Treponema (FOR DONOR TESTING)

  2003-02-21

  Fujirebio Diagnostics, Inc.

• FUJIREBIO DIAGNOSTICS CA 19-9 RIA

  2002-05-09

  FUJIREBIO DIAGNOSTICS, INC.

• OLYMPUS PK(TM) TP

  1989-11-17

  FUJIREBIO DIAGNOSTICS, INC.

GUDID#

• Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio - CL0073

  Fujirebio Diagnostics, Inc.

  2024-11-04

• Beckman Coulter PK TP System Control Set - PH3502

  FUJIREBIO DIAGNOSTICS, INC.

  2016-09-16

• Beckman Coulter PK CMV-PA SYSTEM Control Set - 240226

  FUJIREBIO DIAGNOSTICS, INC.

  2016-09-16

• Serodia TP-PA Kits - 100 test kit

  FUJIREBIO DIAGNOSTICS, INC.

  2023-12-06

• Serodia TP-PA Kits - 220 test kits

  FUJIREBIO DIAGNOSTICS, INC.

  2023-12-06

• Emit Cyclosporine Sample - 4008086

  FUJIREBIO DIAGNOSTICS, INC.

  2023-12-06

• MESOMARK - 801-905

  Fujirebio Diagnostics, Inc.

  2014-09-17

• Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator Tool - Software

  Fujirebio Diagnostics, Inc.

  2022-11-10

• Lumipulse G Wash Solution - 4008248

  FUJIREBIO DIAGNOSTICS, INC.

  2017-10-06

• Lumipulse G ROMA - Software Disk

  Fujirebio Diagnostics, Inc.

  2016-09-19

• ROMA - ROMA (HE4 EIA + ARCHITECT CA125II) Software disk

  Fujirebio Diagnostics, Inc.

  2016-09-19

• Fertility Control - 2130162

  FUJIREBIO DIAGNOSTICS, INC.

  2020-12-07

• Vitamin D Control - 2130166

  FUJIREBIO DIAGNOSTICS, INC.

  2020-07-14

• FITC Anti-Rabies Monoclonal Globulin - 800-092

  FUJIREBIO DIAGNOSTICS, INC.

  2016-09-16

• Serodia TP-PA - 100 test kit

  FUJIREBIO DIAGNOSTICS, INC.

  2016-09-16

• Serodia TP-PA - 220 test kit

  FUJIREBIO DIAGNOSTICS, INC.

  2016-09-16

• Vitamin D Control - 2130152

  FUJIREBIO DIAGNOSTICS, INC.

  2016-09-16

• Syphilis Control - 2130170

  FUJIREBIO DIAGNOSTICS, INC.

  2017-06-23