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Tag Archives: Diasorin Molecular—

FDA clears DiaSorin Bordetella test

Jan. 16, 2019—DiaSorin Molecular has received FDA clearance for its new Simplexa Bordetella Direct test. This CLIA moderate-complexity assay is designed for use on the Liaison MDX to provide qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis. The assay is performed directly from nasopharyngeal swab samples without extraction and provides results in about an hour. “We are very ...

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FDA clears Simplexa group B strep assay

Nov. 27, 2018—DiaSorin Molecular announced that the FDA has cleared its Simplexa GBS Direct assay for diagnostic use. Designed for use on the Liaison MDX instrument, the highly sensitive assay enables qualitative detection of group B Streptococcus nucleic acid from 18- to 24-hour Lim broth enrichments of vaginal/rectal specimen swabs obtained from antepartum women. Assay results can be used as an ...

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DiaSorin gets FDA OK for extended swab samples

June 27, 2018—DiaSorin Molecular received FDA clearance extending the sample type claims of its Simplexa HSV 1 & 2 Direct assay. The clearance expands the type of samples that can be tested, from genital swabs to all cutaneous and mucocutaneous swab samples. The Simplexa HSV 1 & 2 Direct kit real-time PCR assay, for use on DiaSorin’s Liaison MDX instrument, ...

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