Device typeMultiple congenital aneuploidy screening IVD, control: A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple congenital aneuploidies, including (but not limited to) trisomy 13 (Pätau syndrome), trisomy 18 (Edwards syndrome), trisomy 21 (Down syndrome), and sex chromosome aneuploidies.
FDA categoryDna-probe kit, human chromosome
Device ID00884999011663
Catalog number05J36-005
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information