18 results
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42ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Fujirebio Europe N.V.
FDA registration
Fujirebio Europe N.V.·5 products·🇧🇪 Belgium
LiRAS for LiPA HCV v1
FDA UDI
Fujirebio Europe·05414470156870·
INNO-LiPA HCV 2.0 Control
FDA UDI
Fujirebio Europe·05414470816613·
INNO-LiPA HCV 2.0 Genotyping
FDA UDI
Fujirebio Europe·05414470816620·
Auto-LIA 48
FDA UDI
Fujirebio Europe·05414470806294·Instrument
TENDIGO
FDA UDI
Fujirebio Europe·05414470804122·Instrument
Lumipulse G pTau 217 Plasma Calibrators
FDA UDI
Fujirebio Europe·05414470815579·Lumipulse G pTau 217 Plasma Calibrators 1x5C, I...
Lumipulse pTau 217 Plasma Controls
FDA UDI
Fujirebio Europe·05414470815586·Lumipulse pTau 217 Plasma Controls 2x2C, IVD-US
Lumipulse B-Amyloid Plasma Controls
FDA UDI
Fujirebio Europe·05414470815593·Lumipulse B-Amyloid Plasma Controls 2x2C, IVD-US
INNO-LiPA HCV 2.0 Amp
FDA UDI
Fujirebio Europe·05414470816637·
INNO-LiPA HCV 2.0 Genotyping
FDA UDI
Fujirebio Europe·05414470816590·
TENDIGO Disposable Trays
FDA UDI
Fujirebio Europe·05414470804214·Disposable Trays 5 trays per base unit
Auto-LiPA 48
FDA UDI
Fujirebio Europe·05414470806287·Instrument
Lumipulse G pTau 217 Plasma Immunoreaction Cartridges
FDA UDI
Fujirebio Europe·05414470815500·Lumipulse G pTau 217 Plasma Immunoreaction Cart...
INNO-LiPA HCV 2.0 Amp
FDA UDI
Fujirebio Europe·05414470816606·
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
FDA Enforcement
Class II
·Ongoing·Fujirebio Diagnostics, Inc.·February 11, 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
FDA Recall
Open, Classified
·Fujirebio Diagnostics, Inc.·Product code SET·December 11, 2025
ELECSYS ANTI-HCV II
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code MZO·September 19, 2025