Fujirebio Diagnostics, Inc.
Seguin, TX, US
Fujirebio Diagnostics, Inc. appears in FDA device records in Seguin, TX. FDA records list 45 510(k) clearances between and , no PMA records and 4 registered establishments. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 45 510(k) clearances for Fujirebio Diagnostics, Inc. between 1989 and 2025. The busiest year on record is 2011, with 6. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 2002 | 1 |
| 2004 | 3 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 6 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 2 |
| 2016 | 5 |
| 2017 | 6 |
| 2019 | 1 |
| 2020 | 3 |
| 2022 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | OVK | Substantially Equivalent | |
| K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | SET | Substantially Equivalent | |
| DEN200072 | Lumipulse G ß-Amyloid Ratio (1-42/1-40) | QSE | Unknown | |
| K192524 | Lumipulse G CA15-3 | MOI | Substantially Equivalent | |
| K192380 | ST AIA-PACK BNP | NBC | Substantially Equivalent | |
| K200997 | Lumipulse G CA19-9-N | NIG | Substantially Equivalent | |
| K190702 | Lumipulse G whole PTH | CEW | Substantially Equivalent | |
| K172713 | Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set | PRI | Substantially Equivalent | |
| K171103 | Lumipulse G TSH-III Immunoreaction Cartridges | JLW | Substantially Equivalent | |
| K163546 | Lumipulse G Progesterone-N Calibrators | JIT | Substantially Equivalent | |
| K163534 | Lumipulse G FSH-N Calibrators | JIT | Substantially Equivalent | |
| K163544 | Lumipulse G Prolactin | JIT | Substantially Equivalent | |
| K163521 | Lumipulse G LH Calibrators | JIT | Substantially Equivalent | |
| K163053 | Lumipulse G E2-III Calibrators | JIT | Substantially Equivalent | |
| K153145 | Lumipulse G TP-N Immunoreaction Cartridge Set | LIP | Substantially Equivalent | |
| K160090 | Lumipulse G ROMA | ONX | Substantially Equivalent | |
| K151502 | ARCHITECT ROMA | ONX | Substantially Equivalent | |
| K153361 | Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators | MRG | Substantially Equivalent | |
| K151378 | Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators | OIU | Substantially Equivalent | |
| K142895 | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators | LTK | Substantially Equivalent | |
| K140436 | ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS | OSX | Substantially Equivalent | |
| K133197 | FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE | JJX | Substantially Equivalent | |
| K123612 | FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA | JJX | Substantially Equivalent | |
| K103358 | ROMA (HE4 EIA + ARCHITECT CA 125 II) | ONX | Unknown | |
| K103676 | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL | OIU | Substantially Equivalent | |
| K110641 | FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL | JJX | Substantially Equivalent | |
| K100831 | CYFRA 21-1 EIA MODEL 211-10 | OVK | Substantially Equivalent | |
| K110436 | FDI GLUCOSE CONTROL SOLUTION FOR AVIVA | JJX | Substantially Equivalent | |
| K103450 | FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE | JJX | Substantially Equivalent | |
| K101809 | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 | JJY | Substantially Equivalent | |
| K102260 | FDI GLUCOSE CONTROL SOLUTIONS | JJX | Substantially Equivalent | |
| K093957 | ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, | OIU | Substantially Equivalent | |
| K092645 | FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 | JJX | Substantially Equivalent | |
| K080751 | ARCHITECT CYCLOSPORINE | MKW | Substantially Equivalent | |
| K072939 | HE4 EIA, MODEL: 404-10 US | OIU | Substantially Equivalent | |
| K070822 | ARCHITECT SIROLIMUS ASSAY | NRP | Substantially Equivalent | |
| K070820 | ARCHITECT TACROLIMUS: MODEL 1L77 | MLM | Substantially Equivalent | |
| K060964 | ARCHITECT BNP ASSAY, MODEL 8K28 | NBC | Substantially Equivalent | |
| K052889 | VITROS CA 19-9 | NIG | Substantially Equivalent | |
| K052000 | ARCHITECT CA 19-9XR ASSAY | NIG | Substantially Equivalent | |
| K042732 | ARCHITECT CA 15-3 ASSAY | MOI | Substantially Equivalent | |
| K042731 | ARCHITECT CA 125 II ASSAY | LTK | Substantially Equivalent | |
| K033731 | AXSYM CORTISOL ASSAY | JFT | Substantially Equivalent | |
| K020566 | FUJIREBIO DIAGNOSTICS CA 19-9 RIA | NIG | Substantially Equivalent | |
| K893124 | OLYMPUS PK(TM) TP | GMT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3027273565 | 3027273565 | Fujirebio Diagnostics AB | Gemenskapens gata 7, Molndal Vastra Gotaland SE-431 53 SE | 2026 | |
| 3000125561 | 3000125561 | Fujirebio Diagnostics, AB | Elof Lindalvs Gata 13, Gothenburg Vastra Gotaland 41455 SE | 2026 | |
| 1643621 | 1643621 | Fujirebio Diagnostics, Inc. | 940 Crossroads Blvd, Seguin, TX 78155 US | 2026 | and 2 more, listed in full below |
| 2521625 | 2521625 | Fujirebio Diagnostics, Inc. | 201 Great Valley Parkway, Malvern, PA 19355 US | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QSEAlzheimer’S Disease Pathology Assessment Test
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- GMTAntigens, Ha, Treponema Pallidum
- GOIAntiserum, Fluorescent, Rabies Virus
- JITCalibrator, Secondary
- DLJCalibrators, Drug Specific
- MKWCyclosporine
- OVKCytokeratin Fragments 21-1 Eia Kit
- LAOEnzyme Immunoassay, Methotrexate
- MLMEnzyme Immunoassay, Tracrolimus
- LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum
- JFTFluorometric, Cortisol
- OSXGalectin-3 In Vitro Diagnostic Assay
- SETImmunoassay Blood Test For Amyloid Pathology Assessment
- OHQMulti-Analyte Controls Unassayed
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- ONXOvarian Adnexal Mass Assessment Score Test System
- PRIProcalcitonin Assay
- LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers
- CEWRadioimmunoassay, Parathyroid Hormone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- QKOReagent, Coronavirus Serological
- OTRResearch Use Only/Immunology Devices
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- NRPSirolimus Test System
- KSZSystem, Test, Automated Blood Grouping And Antibody
- NIGSystem, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
- MOISystem, Test, Immunological, Antigen, Tumor
- MSWSystem, Test, Thyroglobulin
- MRGSystem, Test, Vitamin D
- OIUTest, Epithelial Ovarian Tumor Associated Antigen (He4)
- LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
- NBCTest, Natriuretic Peptide
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1307-2026 | Product Name: Lumipulse -Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse -Amyloid Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing -amyloid1-42 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range. Lumipulse -Amyloid Plasma Controls: Liquid (Frozen), 2 2 Concentrations L1 Level 1 (2 1.5 mL) L2 Level 2 (2 1.5 mL) Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). | Class II | Open, Classified | |
| Z-1306-2026 | Product Name: Lumipulse G -Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G -Amyloid 1-42-N Plasma Calibrators: The -Amyloid 1-42 plasma concentration of a specimen is automatically calculated from the calibration curve, which is automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G -Amyloid 1-42-N Plasma Calibrators: Liquid (Frozen), 1 1.5 mL (4 Concentrations) CAL 1 0 pg/mL -Amyloid 1-42-N Plasma Calibrator CAL 2 30 pg/mL -Amyloid 1-42-N Plasma Calibrator CAL 3 100 pg/mL -Amyloid 1-42-N Plasma Calibrator CAL 4 1000 pg/mL -Amyloid 1-42-N Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 950. Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). | Class II | Open, Classified | |
| Z-1305-2026 | Product Name: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): Lumipulse G -Amyloid 1-42-N Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G -Amyloid 1-42-N Plasma IRC), for the quantitative measurement of -Amyloid 1-42 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology13 by a specific two-step immunoassay method on the LUMIPULSE G System. Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): 3 14 Tests: 3 racks, 14 IRCs per rack, 1 test per IRC. Each IRC contains (abbreviated contents): 1. Antibody-Coated Particle Solution: (Contains anti--amyloid 1-42 monoclonal antibody (mouse)-coated particles). This solution contains gelatin and turns into gel at 15C or lower, 2. Enzyme-Labeled Antibody Solution: (Contains alkaline phosphatase (ALP)-labeled anti--amyloid 1-42 monoclonal antibodies (mouse) conjugate), 3. Assay Specific Solution: (Contains detergents in 50 mM MES buffer) Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). | Class II | Open, Classified | |
| Z-1304-2026 | Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing pTau 217 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range. Lumipulse pTau 217 Plasma Controls: Liquid (Frozen), 2 2 Concentrations L1 Level 1 (2 1.5 mL) L2 Level 2 (2 1.5 mL) Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 300, 0.05% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). | Class II | Open, Classified | |
| Z-1303-2026 | Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration curve, which is also automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G pTau 217 Plasma Calibrators: Liquid (Frozen), 1x1.5 mL (5 Concentrations) CAL 1 0 pg/mL pTau 217 Plasma Calibrator CAL 2 0.250 pg/mL pTau 217 Plasma Calibrator CAL 3 1.000 pg/mL pTau 217 Plasma Calibrator CAL 4 5.000 pg/mL pTau 217 Plasma Calibrator CAL 5 10.000 pg/mL pTau 217 Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 300, 0.05% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). | Class II | Open, Classified | |
| Z-1302-2026 | Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC): Lumipulse G pTau 217 Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G pTau 217 Plasma IRC), for the quantitative measurement of pTau 217 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology by a specific two-step immunoassay method on the LUMIPULSE G System. 3 14 Tests: 3 racks, 14 IRCs per rack, 1 test per IRC. Each IRC contains (abbreviated contents): 1. Antibody-Coated Particle Solution: (Contains anti-phosphorylated Tau (217) monoclonal antibody (mouse)-coated particles). This solution contains gelatin and turns into gel at 15C or lower, 2. Enzyme-Labeled Antibody Solution: (Contains alkaline phosphatase (ALP)-labeled anti-Tau monoclonal antibodies (mouse) conjugate), 3. Assay Specific Solution: (Contains chemical stabilizers in 50 mM Tris buffer) Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). | Class II | Open, Classified | |
| Z-1301-2026 | Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G -Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with each individual Lumipulse G assay. Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio, Item# CL0073 is comprised of the following kits, which are imported: Kit Description, Item#: Imported from Fujirebio Europe (FRE): Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550 Lumipulse G pTau 217 Plasma Calibrators set 81557 Lumipulse pTau 217 Plasma Controls 81558 Lumipulse -Amyloid Plasma Controls 81559 Imported from Fujirebio Japan (FRI): Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges 235447 Lumipulse G -Amyloid 1-42-N Plasma Calibrators set 235454 Component: No | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). | Class II | Open, Classified | |
| Z-1606-2011 | MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed with mesothelioma. Each kit contains 96 tests. MESOMARK is an enzyme linked immunosorbent assay (ELISA) for the quantitative measurement of Soluble mesothelin Related Peptides (SMRP) in human serum. Measurement of SMRP may aid in the monitoring of patients diagnosed with epithelioid or biphasic mesothelioma. MESOMARK values must be interpreted in conjunction with all other available clinical and laboratory data. | presence of material attached to the bottom of some wells in places visible to the naked eye, which caused an overestimation of the sample. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain