Device typeHuman epidermal growth factor receptor 2 (HER2) protein IVD, control: A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of human epidermal growth factor receptor 2 (HER2) protein, also known as HER2 or neu oncoprotein, in a clinical specimen.
FDA categorySystem, automated scanning microscope and image analysis for fluorescence in situ hybridization (fish) assays
Device ID00884999001824
Catalog number02J04-010
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information