Isohelix said on Monday that their complete range of GeneFiX DNA Saliva Collectors have been fully registered with the CFDA in the People’s Republic of China as certified IVD medical devices. The registration process allows Isohelix and its partners to substantially develop this territory with the knowledge of a ‘full market clearance’, thus elevating the presence of Isohelix as manufacturers of DNA and RNA Saliva Collection products within one of the largest international markets.
Tom Hole, CEO of Isohelix further comments, “This exciting registration is filed alongside other existing and important worldwide registrations such as the CE/IVD certification, which further strengthens the products significant commercial position in many of the most important healthcare territories in the world.”
Isohelix manufactures a broad range of DNA and RNA Saliva and Buccal Cell collection devices designed for medical, diagnostic and research use, together with innovative ranges of kits for the stabilization and high purity extraction of DNA and RNA, using both manual and automated methodologies. In addition, the company also has joint ventures with a number of diagnostic and medical companies to improve the DNA and RNA collection process to increase either ease of use, purity or yields during the sampling and purification stages.
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