VITROS CEA Calibrators

FDA registration

ORTHO-CLINICAL DIAGNOSTICS, INC.·2 products·🇺🇸 United States

Dimension Vista CEA Flex

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS INC.·2 products·🇺🇸 United States

VITROS CEA Calibrators

FDA registration

Ortho Clinical Diagnostics·2 products·🇸🇬 Singapore

ST AIA-PACK CEA

FDA registration

TOSOH AIA, INC.·2 products·🇯🇵 Japan

VITROS Immunodiagnostic Products CEA Reagent Pack

FDA 510(k)

FDA Class 2 ·Immunology

THREE LEVEL CONTROL SERA

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Centaur CEA Assay

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209

FDA 510(k)

FDA Class 2 ·Immunology

AIA-PACK CEA CALIBRATION VERIFICATION TEST SET

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS

FDA 510(k)

FDA Class 2 ·Immunology

CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV

FDA 510(k)

FDA Class 2 ·Immunology

TRI-LEVEL LIGAND CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

CEA CONTROL PLASMA

FDA 510(k)

FDA Class 2 ·Immunology

ACS:CENTAUR CEA

FDA 510(k)

FDA Class 2 ·Immunology

VIDAS CEA (S) ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

NORMAL GOAT SERUM

FDA 510(k)

FDA Class 2 ·Immunology

CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ABBOTT ARCHITECT CEA

FDA 510(k)

FDA Class 2 ·Immunology

OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN

FDA 510(k)

FDA Class 2 ·Immunology