ELECSYS CA 125II ON THE ELECSYS 1010

FDA 510(k)

FDA Class 2 ·Immunology

Access OV Monitor

FDA 510(k)

FDA Class 2 ·Immunology

VITROS Immuodiagnostic Products CA 125 II Reagent Pack

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS OV MONITOR ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS CA 125 II

FDA 510(k)

FDA Class 2 ·Immunology

VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK

FDA 510(k)

FDA Class 2 ·Immunology

CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

VIDAS CA 125 II ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT CA 125 II ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Alinity i CA 125II

FDA registration

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

Alinity i CA 125 II Reagent Kit - LN 08P4920 and 08P4930

FDA registration

ABBOTT LABORATORIES·3 products·🇺🇸 United States

Lumipulse G Wash Solution 4008248

FDA registration

Fujirebio Inc.·3 products·🇯🇵 Japan

Lumipulse G Wash Solution 4008248

FDA registration

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

Lumipulse G Wash Solution 4008248

FDA registration

Fujirebio Inc. Ube Facility·3 products·🇯🇵 Japan

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TVL(TM) LEAD SYSTEM

ARCHITECT

FDA UDI

ABBOTT LABORATORIES·00380740003388·ARCHITECT CA125 II Reagent Kit

ARCHITECT

FDA UDI

ABBOTT LABORATORIES·00380740003371·ARCHITECT CA125 II Controls

ARCHITECT

FDA UDI

ABBOTT LABORATORIES·00380740003364·ARCHITECT CA125 II Calibrators

ARCHITECT

FDA UDI

ABBOTT LABORATORIES·00380740003395·ARCHITECT CA125 II Reagent Kit