Device typeHuman epidermal growth factor receptor 2 (HER2) protein IVD, reagent: A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is 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, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
Device ID00884999001756
Catalog number02J01-035
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information