NEW YORK (GenomeWeb) – Illumina has registered its MiSeqDx instrument for clinical use in Australia, the company said today. The Australian Therapeutic Goods Administration has listed the instrument in the Australian Register of Therapeutic Goods as a cleared in vitro diagnostic medical device, Illumina said.
"This is an exciting milestone for Illumina and for our clinical customers in Australia," Tim Orpin, vice president and general manager for Illumina in the Asia Pacific region, said in a statement.
Earlier this month, Illumina received approval from South Korea's Ministry of Food and Drug Safety to use its MiSeqDx instrument and MiSeqDx Universal kit for diagnostic purposes.
The instrument is now cleared for clinical use in the US, Canada, Argentina, European countries recognizing the CE mark, Australia, South Korea, Singapore, Thailand, and the Philippines.
Illumina also has 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.