Device typeDNA anti-contamination enzyme reagent IVD: A substance or reactant intended to be used as a hydrolyzing enzyme in a molecular assay to prevent contamination of the resulting deoxyribonucleic acid (DNA) amplicon, by preventing unintentional carry over of amplification products from a previous assay, in the analysis of a clinical laboratory specimen, using a polymerase chain reaction (PCR) technique.
FDA categoryAssay, genotyping, hepatitis c virus
Device ID00884999036444
Catalog number08L21-66
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information