WebThe FDA granted marketing authorization of the AmplideX Fragile X Dx and Carrier Screen Kit to Asuragen Inc. The FDA, an agency within the U.S. Department of Health and Human Services, protects ... WebJan 25, 2024 · The AmplideX® PCR/CE C9orf72 Kit is a research tool for the reliable amplification of pathogenic hexanucleotide repeats (GGGGCC) in the C9orf72 gene that are associated with amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). Using our proprietary GC-rich PCR chemistry and building on the success of our …
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WebDec 1, 2024 · The Asuragen kit will include reagents and tools for target enrichment, analysis software, and use a workflow that integrates Oxford Nanopore's library preparation reagents and sequencing instruments. WebNov 25, 2024 · Asuragen to Develop IVD Kits on Thermo Fisher Scientific's CE Platform . Dec 12, 2016. Asuragen Research Correlates FMR1 Methylation, Symptoms in Fragile X-Associated Motor Disorder. Premium. Jul 25, 2016. Asuragen BCR-ABL Kit Granted FDA Premarket Clearance. May 19, 2016. timing-function属性
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WebAreas Covered: The AmplideX Fragile X Dx and Carrier Screen Kit (Asuragen, Inc.) represents a refined assay that underwent validation with sensitivity analyses for FDA approval. Single-site precision, analytical sensitivity and specificity, limit of detection and diagnostic performance were assessed in comparison to reference methods at three ... WebAsuragen Launches New Kit to Enable Broader Coverage of Gene Variants Linked to Cystic Fibrosis MINNEAPOLIS, Nov. 8, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ:TECH) today announced that Asuragen, Inc., a Bio-Techne brand, has launched a new kit to detect pathogenic variants in the CFTR gene. The AmplideX® PCR/CE … WebAsuragen . F. Proprietary and Established Names: Trade Name: QuantideX qPCR BCR-ABL IS Kit . Common Name: BCR-ABL1 RT-qPCR Test . G. Regulatory Information: 1. Regulation section: ... Stability testing was performed on 3 assay kit lots, 5 kits from each lot, 1 kit tested per cycle (per calendar week). The acceptance criteria were results within ... parkmore farm dufftown