GenetiSure Dx Postnatal Assay Ordering Information

Part Number Components Contents K1201A Agilent GenetiSure Dx Postnatal Assay 6 slides 4x and 6 coverslips, 24 samples K1201-64100 Agilent GenetiSure Dx DNA Labeling Kit 25 samples and 25 reference reactions K1201-64200 Agilent GenetiSure Dx Hybridization Kit 25 hybridization slides reagents K1201-64300 Agilent GenetiSure Dx Wash Buffer Set 8 L wash buffer 1; 4 L wash buffer 2 reagents K1201-64400 Agilent GenetiSure Dx Cot-1 Human DNA 625 µL, 1 µg/µL reagent GenetiSure Dx Postnatal Bundles: Part Number Components Contents K1202B Agilent GenetiSure Dx Postnatal Bundle 24 rx 6 slides (24 arrays), backing slides, sufficient reagents and consumables to process 24 samples K1202C Agilent GenetiSure Dx Postnatal Bundle 48 rx 12 slides (48 arrays), backing slides, sufficient reagents and consumables to process 48 samples Part Number Equipment G5761AA SureScan Dx Microarray Scanner Bundle G2534A Hybridization Chamber Kit, SureHyb enabled, Stainless G2545A Microarray Hybridization Oven G2530-60029 Hybridization Oven Rotator Rack

INTENDED USE: GenetiSure Dx Postnatal Assay is a qualitative assay intended for the postnatal detection of copy-number variations (CNV) and copy-neutral loss of heterozygosity (cnLOH) in genomic DNA obtained from peripheral whole blood in patients referred for chromosomal testing based on clinical presentation. GenetiSure Dx Postnatal Assay is intended for the detection of CNVs and cnLOH associated with developmental delay, intellectual disability, congenital anomalies or dysmorphic features. Assay results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, parental evaluation, clinical genetic evaluation and counseling, as appropriate. Interpretation of assay results is intended to be performed only by healthcare professionals who are board-certified in clinical cytogenetics or molecular genetics.

The assay is intended to be used on the SureScan Dx Microarray Scanner System and analyzed by CytoDx Software.

WARNING: This device is not intended to be used for standalone or diagnostic purposes, pre-implantation or prenatal testing or screening, population screening or the detection of, or screening for, acquired or somatic genetic aberrations.

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GenetiSure Dx POSTNATAL ASSAY

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