OIU / Test, epithelial ovarian tumor associated antigen (he4)

FDA registration

MONOCENT INC.·1 product·🇺🇸 United States

SKT-033 Human Epididymal protein 4 (HE4) CLIA Kit

FDA registration

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

HE4 EIA

FDA registration

Fujirebio Diagnostics AB·1 product·🇸🇪 Sweden

HE4 EIA

FDA registration

Fujirebio Diagnostics, AB·1 product·🇸🇪 Sweden

HE4 ELISA

FDA registration

IMMUNOCENTRIX CORPORATION·1 product·🇺🇸 United States

Alinity i HE4 Reagent Kit

FDA registration

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

Lumipulse G HE4 Immunoreaction Cartridges

FDA UDI

FUJIREBIO INC.·04987270234174·

Elecsys HE4

FDA UDI

Roche Diagnostics GmbH·04015630940219·

Elecsys HE4 Assay

FDA UDI

Roche Diagnostics GmbH·04015630929641·

Alinity

FDA UDI

Abbott GmbH·00380740138349·Alinity i HE4 Reagent Kit 200 Tests

HE4 EIA

FDA UDI

Fujirebio Diagnostics AB·17350066140326·

ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,

FDA 510(k)

FDA Class 2 ·Immunology

HE4 EIA, MODEL: 404-10 US

FDA 510(k)

FDA Class 2 ·Immunology

FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators

FDA 510(k)

FDA Class 2 ·Immunology

HE4 CC 5 Elecsys

FDA registration

ROCHE DIAGNOSTICS GMBH·3 products·🇩🇪 Germany

Alinity i HE4 Reagents

FDA registration

Fujirebio Diagnostics, Inc.·3 products·🇺🇸 United States

ARCHITECT HE4 Reagent Kit - LN 02P5427

FDA registration

ABBOTT LABORATORIES·3 products·🇺🇸 United States

ARCHITECT

FDA UDI

Abbott GmbH·00380740003975·ARCHITECT HE4 Calibrators