14 results
·
121ms
·
Sources: EU EUDAMED, US FDA
N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
THYROXINE (FPIA) KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
THYROXINE CALIBRATOR KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VALPROIC ACID (FPIA) CALIBRATOR KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PRIMIDONE (FPIA) KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DIGITOXIN (FPIA) KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
VALPROIC ACID (FPIA) KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PRIMIDONE (FPIA) CALIBRATOR KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationFocus CDx BRCA HRD
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationFocus CDxBRCA
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·RESOLUTION ctDx FIRST
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Guardant360 CDx
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·myChoice CDx