NEW YORK (GenomeWeb) – Illumina has received a product approval certificate for clinical use for its MiSeqDx instrument and MiSeqDx Universal kit from South Korea's Ministry of Food and Drug Safety.
The registration allows Illumina to sell its instrument to clinical laboratories in South Korea, and will "accelerate the process for us to get other Illumina clinical products into this market in the future," Jason Kang, Illumina's commercial leader in South Korea, said in a statement.
Tim Orpin, Illumina's vice president and general manager, added that the registration is "an exciting milestone," and the first step of the company's regulatory strategy in the Asia Pacific region.
Illumina received premarket clearance from US Food and Drug Administration for the MiSeqDx in November 2013 and a medical device license for the instrument from Health Canada in 2015. MiSeqDx also has CE marking in Europe.
Illumina also received premarket clearance for a version of its NextSeq 500 instrument from the China Food and Drug Administration in conjunction with Berry Genomics' noninvasive prenatal test.