Device typeExogenous DNA/RNA internal control IVD, kit: A collection of reagents and other associated materials intended to be used as an exogenous component in a molecular assay, to verify the extraction and/or amplification process applied to target deoxyribonucleic acid (DNA) and/or ribonucleic acid (RNA), and/or to verify the absence of inhibiting substances in a clinical specimen.
FDA categoryNucleic acid amplification assay system, group b streptococcus, direct specimen test
Device ID15420045510470
Catalog numberPRD-04476
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information