Fujirebio Diagnostics,Inc.
Medical device manufacturer in Malvern, PA.
44510(k) clearances
0PMA approvals
8recalls
Device types
- JJX Single (Specified) Analyte Controls… 7
- JIT Calibrator, Secondary 5
- NIG System, Test, Carbohydrate Antigen… 4
- OIU Test, Epithelial Ovarian Tumor Associated… 4
- ONX Ovarian Adnexal Mass Assessment Score Test… 3
- NBC Test, Natriuretic Peptide 2
- OVK Cytokeratin Fragments 21-1 Eia Kit 2
- LTK Test, Epithelial Ovarian Tumor-Associated… 2
- MOI System, Test, Immunological, Antigen, Tumor 2
- NRP Sirolimus Test System 1
- MKW Cyclosporine 1
- JFT Fluorometric, Cortisol 1
- JJY Multi-Analyte Controls, All Kinds (Assayed) 1
- MLM Enzyme Immunoassay, Tracrolimus 1
- OSX Galectin-3 In Vitro Diagnostic Assay 1
- MRG System, Test, Vitamin D 1
- LIP Enzyme Linked Immunoabsorption Assay… 1
- GMT Antigens, Ha, Treponema Pallidum 1
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 1
- PRI Procalcitonin Assay 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K250925 | ADVIA Centaur Cytokeratin Fragment 21-1OVK · Traditional | 12/16/2025SE |
| K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioSET · Traditional | 05/16/2025SE |
| K192524 | Lumipulse G CA15-3MOI · Traditional | 09/04/2020SE |
| K192380 | ST Aia-Pack BNPNBC · Traditional | 08/24/2020SE |
| K200997 | Lumipulse G CA19-9-NNIG · Special | 05/14/2020SE |
| K190702 | Lumipulse G whole PTHCEW · Traditional | 08/30/2019SE |
| K172713 | Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT…PRI · Traditional | 12/10/2017SE |
| K171103 | Lumipulse G TSH-III Immunoreaction CartridgesJLW · Traditional | 07/28/2017SE |
| K163546 | Lumipulse G Progesterone-N CalibratorsJIT · Abbreviated | 01/13/2017SE |
| K163534 | Lumipulse G FSH-N CalibratorsJIT · Abbreviated | 01/13/2017SE |
| K163544 | Lumipulse G ProlactinJIT · Abbreviated | 01/12/2017SE |
| K163521 | Lumipulse G LH CalibratorsJIT · Abbreviated | 01/12/2017SE |
| K163053 | Lumipulse G E2-III CalibratorsJIT · Abbreviated | 12/01/2016SE |
| K153145 | Lumipulse G TP-N Immunoreaction Cartridge SetLIP · Traditional | 07/05/2016SE |
| K160090 | Lumipulse G ROMAONX · Traditional | 05/16/2016SE |
| K151502 | Architect RomaONX · Traditional | 04/28/2016SE |
| K153361 | Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D CalibratorsMRG · Traditional | 04/15/2016SE |
| K151378 | Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 CalibratorsOIU · Traditional | 11/24/2015SE |
| K142895 | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA…LTK · Traditional | 05/21/2015SE |
| K140436 | ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3…OSX · Traditional | 12/23/2014SE |
| K133197 | Fdi Level I and Level II Glucose Controls for the Embrace No CodeJJX · Traditional | 01/17/2014SE |
| K123612 | Fdi Glucose Control Solution for Use with Accu-Chek AvivaJJX · Traditional | 01/17/2013SE |
| K103358 | Roma (HE4 Eia + Architect Ca 125 II)ONX · Traditional | 09/01/2011SESU |
| K103676 | Fujirebio Diagnostics Tumor Marker ControlOIU · Traditional | 07/19/2011SE |
| K110641 | Fujirebio Diagnostics Vitamin D ControlJJX · Traditional | 05/27/2011SE |
| K100831 | Cyfra 21-1 Eia Model 211-10OVK · Traditional | 05/26/2011SE |
| K110436 | Fdi Glucose Control Solution for AvivaJJX · Traditional | 04/20/2011SE |
| K103450 | Fdi Glucose Control Solution for FreestyleJJX · Traditional | 01/25/2011SE |
| K101809 | Fujirebio Diagnostics Tumor Marker Control Model 108-20JJY · Traditional | 10/05/2010SE |
| K102260 | Fdi Glucose Control SolutionsJJX · Traditional | 09/24/2010SE |
| K093957 | Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2, 2P54…OIU · Traditional | 03/18/2010SE |
| K092645 | Fdi Glucose Control Levels 1, 2 and 3JJX · Traditional | 09/05/2009SE |
| K080751 | Architect CyclosporineMKW · Traditional | 09/11/2008SE |
| K072939 | HE4 Eia, Model: 404-10 USOIU · Traditional | 06/09/2008SE |
| K070822 | Architect Sirolimus AssayNRP · Traditional | 09/28/2007SE |
| K070820 | Architect Tacrolimus: Model 1L77MLM · Traditional | 08/01/2007SE |
| K060964 | Architect BNP Assay, Model 8K28NBC · Traditional | 05/25/2006SE |
| K052889 | Vitros Ca 19-9NIG · Traditional | 12/20/2005SE |
| K052000 | Architect Ca 19-9XR AssayNIG · Traditional | 10/25/2005SE |
| K042732 | Architect Ca 15-3 AssayMOI · Traditional | 12/22/2004SE |
| K042731 | Architect Ca 125 II AssayLTK · Traditional | 11/19/2004SE |
| K033731 | Axsym Cortisol AssayJFT · Traditional | 02/20/2004SE |
| K020566 | Fujirebio Diagnostics Ca 19-9 RiaNIG · Traditional | 05/09/2002SE |
| K893124 | Olympus Pk(Tm) TPGMT · Traditional | 11/17/1989SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1307-2026 Class II | Product Name: Lumipulse -Amyloid Plasma Controls Model/Catalog Number: 81559 Software…Customers may experience inaccurate test results by observing a higher frequency of classification in the… | 12/11/2025Open, Classified |
| Z-1306-2026 Class II | Product Name: Lumipulse G -Amyloid 1-42-N Plasma Calibrators Model/Catalog Number:…Customers may experience inaccurate test results by observing a higher frequency of classification in the… | 12/11/2025Open, Classified |
| Z-1305-2026 Class II | Product Name: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog…Customers may experience inaccurate test results by observing a higher frequency of classification in the… | 12/11/2025Open, Classified |
| Z-1304-2026 Class II | Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software…Customers may experience inaccurate test results by observing a higher frequency of classification in the… | 12/11/2025Open, Classified |
| Z-1303-2026 Class II | Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557…Customers may experience inaccurate test results by observing a higher frequency of classification in the… | 12/11/2025Open, Classified |
| Z-1302-2026 Class II | Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog…Customers may experience inaccurate test results by observing a higher frequency of classification in the… | 12/11/2025Open, Classified |
| Z-1301-2026 Class II | Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number:…Customers may experience inaccurate test results by observing a higher frequency of classification in the… | 12/11/2025Open, Classified |
| Z-1606-2011 | MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring…presence of material attached to the bottom of some wells in places visible to the naked eye, which caused… | 07/29/2010Terminated |