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These technologies generally can be grouped into three approaches: polymerase chain reaction (PCR), hybridization, and next-generation sequencing (NGS). [22] Currently, a lot of PCR and hybridization assays have been approved by FDA as in vitro diagnostics. [47] NGS assays, however, are still at an early stage in clinical diagnostics. [48]
Illumina claimed that Oxford Nanopore infringed its patents on the use of a biological nanopore, Mycobacterium smegmatis porinA (MspA), for sequencing systems. [64] [65] In August 2016 the parties settled their lawsuit. [66] In February 2020, Illumina filed a patent infringement suit against BGI relating to its "CoolMPS" sequencing products. [67]
In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) expanded the FDA's authorities and strengthened the Agency's ability to safeguard and advance public health. Among other authorities, FDASIA permitted FDA to publish regulations establishing a Unique Device Identification (UDI) system for medical devices.
The iHealth COVID-19 test is easy to use and accurate, according to more than 7,600 shoppers.
The proximity extension assay (PEA) is a method for detecting and quantifying the amount of many specific proteins present in a biological sample such as serum or plasma. [1] The method is used in the research field of proteomics , specifically affinity proteomics, [ 2 ] where in one searches for differences in the abundance of many specific ...
Single-cell sequencing examines the nucleic acid sequence information from individual cells with optimized next-generation sequencing technologies, providing a higher resolution of cellular differences and a better understanding of the function of an individual cell in the context of its microenvironment. [1]