3,273 results · 47ms · Sources: EU EUDAMED, US FDA

Elecsys CA 15-3 II

FDA 510(k)
FDA Class 2 ·Immunology

Elecsys CA 15-3 II

FDA 510(k)
FDA Class 2 ·Immunology

ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647

FDA 510(k)
FDA Class 2 ·Immunology

IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR

FDA 510(k)
FDA Class 2 ·Immunology

VITROS Immunodiagnostic Products CEA Reagent Pack

FDA 510(k)
FDA Class 2 ·Immunology

ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY

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

THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

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

LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators

FDA 510(k)
FDA Class 2 ·Immunology

ACS:CENTAUR CEA

FDA 510(k)
FDA Class 2 ·Immunology

AXSYM CA 125

FDA 510(k)
FDA Class 2 ·Immunology

IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA

FDA 510(k)
FDA Class 2 ·Immunology