515 results · 44ms · Sources: EU EUDAMED, US FDA

Lumipulse G ?-Amyloid Ratio (1-42/1-40)

FDA registration
Fujirebio Diagnostics, Inc.·1 product·🇺🇸 United States

beta-Amyloid(1-42) G2 Elecsys E2G 100

FDA registration
ROCHE DIAGNOSTICS GMBH·1 product·🇩🇪 Germany

Lumipulse G pTau 217 Plasma Calibrators

FDA registration
Fujirebio Diagnostics, Inc.·1 product·🇺🇸 United States

Lumipulse G ?-Amyloid Ratio (1-42/1-40)

FDA registration
Fujirebio Inc.·1 product·🇯🇵 Japan

CL0080 Total-tau CLIA Kit

FDA registration
EPITOPE DIAGNOSTICS, INC.·1 product·🇺🇸 United States

Lumipulse G pTau 217 Plasma Calibrators

FDA registration
Fujirebio Europe N.V.·1 product·🇧🇪 Belgium

Lumipulse G pTau 217 Plasma Calibrators

FDA registration
Fujirebio Inc.·1 product·🇯🇵 Japan

beta-Amyloid(1-42) G2 Elecsys cobas e 60

FDA registration
ROCHE DIAGNOSTICS GMBH·1 product·🇩🇪 Germany

Elecsys Total -Tau CSF

FDA UDI
Roche Diagnostics GmbH·07613336221761·

Elecsys Phospho-Tau (181P) CSF

FDA UDI
Roche Diagnostics GmbH·07613336208366·

Elecsys beta-Amyloid (1-42) CSF II

FDA UDI
Roche Diagnostics GmbH·07613336166321·

Elecsys Total-Tau CSF

FDA UDI
Roche Diagnostics GmbH·07613336167649·

Elecsys Phospho-Tau (181P) CSF

FDA UDI
Roche Diagnostics GmbH·07613336167663·

Elecsys Beta-Amyloid (1-42) CSF II

FDA UDI
Roche Diagnostics GmbH·07613336208359·

Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF

FDA 510(k)
FDA Class 2 ·Immunology

Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio

FDA 510(k)
FDA Class 2 ·Immunology

Lumipulse G ß-Amyloid Ratio (1-42/1-40)

FDA 510(k)
FDA Class 2 ·Immunology

Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF

FDA 510(k)
FDA Class 2 ·Immunology

Alzheimer’S Disease Pathology Assessment Test

FDA classification
FDA Class 2 ·Alzheimer’S Disease Pathology Assessment Test

Immunoassay Blood Test For Amyloid Pathology Assessment

FDA classification
FDA Class 2 ·Immunoassay Blood Test For Amyloid Pathology Assessment