9 July 2009 - Osmetech plc (OMH.L), the fast growing international molecular diagnostics company announces that it has received US Food & Drug Administration (‘FDA’) 510(k) clearance for its eSensor® Cystic Fibrosis Genotyping Test for use on the eSensor® XT-8 System. This multiplex test is used for cystic fibrosis carrier screening for adults of reproductive age, as an aid in newborn screening for cystic fibrosis, and as a confirmatory diagnostic test for cystic fibrosis in newborns and children... Osmetech's Press Release -
Jul 18, 2009
Osmetech : FDA clears its Cystic Fibrosis Genotyping Test
9 July 2009 - Osmetech plc (OMH.L), the fast growing international molecular diagnostics company announces that it has received US Food & Drug Administration (‘FDA’) 510(k) clearance for its eSensor® Cystic Fibrosis Genotyping Test for use on the eSensor® XT-8 System. This multiplex test is used for cystic fibrosis carrier screening for adults of reproductive age, as an aid in newborn screening for cystic fibrosis, and as a confirmatory diagnostic test for cystic fibrosis in newborns and children... Osmetech's Press Release -
