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Tag Archives: DiaSorin

FDA clears Simplexa COVID-19, flu A/B assay

April 2023—DiaSorin has received FDA 510(k) clearance for its Simplexa COVID-19 and Flu A/B Direct assay. The test is a real-time RT-PCR assay that detects and differentiates influenza A, influenza B, and SARS-CoV-2 viruses and is performed using nasopharyngeal swab samples. Results are available in a little more than an hour on the Liaison MDX instrument.  

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FDA clears Simplexa Congenital CMV Direct assay

January 2023—DiaSorin announced it has received FDA 510(k) clearance for its Simplexa Congenital CMV Direct kit. The molecular diagnostic test enables direct detection of cytomegalovirus DNA in saliva swab and urine specimens from babies 21 days old or younger. It is the first kit to receive FDA clearance for CMV detection from both saliva swab and urine specimens.

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DiaSorin gets FDA clearance for PCT assay

April 6, 2018—DiaSorin received clearance from the Food and Drug Administration to market the Liaison Brahms PCT II Gen assay for the quantitative determination of procalcitonin. “I am pleased to announce the addition of the Brahms PCT II Gen assay to our growing specialty menu in the U.S. market”, John Walter, president of DiaSorin, said in a statement. “I’m proud ...

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Qiagen, DiaSorin partnership, 2/18

February 2018—Qiagen and DiaSorin announced a partnership in which Qiagen’s QuantiFeron-TB diagnostic test will be added to the menu of DiaSorin’s Liaison family of analyzers, enabling customers of both companies to process QuantiFeron-TB Gold Plus, a fourth-generation assay for latent tuberculosis detection, on Liaison platforms. QFT-Plus is the first assay from the QuantiFeron portfolio that is planned to be adapted for use on the Liaison systems, with additional assays under consideration.

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FDA clearance for parathyroid hormone assay, 7/14

July 2014—DiaSorin received FDA clearance for its Liaison N-Tact PTH Gen II immunoassay, intended for the quantitative determination of intact human parathyroid hormone in human serum and plasma samples. The kit contains 200 tests and has an open-kit shelf life of 8 weeks, meeting the needs of small- and large-volume laboratories. It also has low cross-reactivity to the 7-84 and other inactive fragments, supporting conservative patient management.

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IGF-1 assay, 7/13:108

DiaSorin’s Liaison IGF-1 assay is a solution for full automation of growth factor testing on a random-access analyzer, for accurately monitoring growth dysfunctions. The company offers an extensive menu of reliable, fully automated chemiluminescent assays suitable for endocrinology clinics, reference laboratories, hospitals, and physician office laboratories. Patients benefit from rapid and accurate results, and laboratories benefit from fast turnaround time and ease of use with the Liaison assay product portfolio.

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Aldosterone assay, 7/13:105

DiaSorin has received FDA clearance for its Liaison aldosterone immunoassay, which is intended for the quantitative determination of aldosterone in human serum, EDTA plasma, and urine samples. The test is used primarily for the diagnosis of hypertension.

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