366 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Helix Laboratory Platform
FDA 510(k)
FDA Class 2
·Medical Genetics
Whole Exome Sequencing Constituent Device
FDA classification
FDA Class 2
·Whole Exome Sequencing Constituent Device
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
ADVIA Centaur CA 15-3 assay
FDA 510(k)
FDA Class 2
·Immunology
ST AIA-PACK CA 19-9
FDA 510(k)
FDA Class 2
·Immunology
ACS:CENTAUR PSA2 IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST
FDA 510(k)
FDA Class 2
·Immunology
ARCHITECT CA 15-3 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
VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
FDA 510(k)
FDA Class 2
·Immunology
NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240
FDA 510(k)
FDA Class 2
·Immunology
ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
FDA 510(k)
FDA Class 2
·Immunology
ST AIA-PACK AFP ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
ELECSYSCA 15-3 II ASSAY
FDA 510(k)
FDA Class 2
·Immunology
AIA-PACK CEA CALIBRATION VERIFICATION TEST SET
FDA 510(k)
FDA Class 2
·Immunology
ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)
FDA 510(k)
FDA Class 2
·Immunology
CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM
FDA 510(k)
FDA Class 2
·Immunology