Details
Device typePCR/NAT negative control IVD: A material or solution, known to give a negative result, intended to be used to verify the performance and/or identify contamination, or non-specific amplification in a qualitative and/or quantitative assay performed on a clinical specimen using a nucleic acid technique (NAT) or polymerase chain reaction (PCR).
FDA categoryNext generation sequencing oncology panel, somatic or germline variant detection system
Device ID10190302000888
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information