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Chronological index
2013–2016

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CMS approves the CAP’s clinical data registry

May 16, 2017—The College of American Pathologists announced that the Pathologists Quality Registry has been approved as a Qualified Clinical …

Roche’s Cobas e 801 510(k) cleared

May 11, 2017—Roche announced that its new, dedicated high-volume testing immunoassay solution for the Cobas 8000 modular analyzer series, the …

High-throughput immunoassay system

May 4, 2017—Siemens Healthineers Advia Centaur XPT Immunoassay System offers a comprehensive infectious disease testing menu for laboratory…

CE mark for Allegro analyzer

May 1, 2017—Nova Biomedical received CE mark certification for its Allegro capillary blood analyzer for point-of-care testing in primary care …

Alere Reader platform FDA cleared

April 27, 2017—Alere announced the introduction of its Alere Reader, an FDA 510(k)-cleared diagnostic platform with objective result interpretation and …

Emergency use authorization for Zika IgM test

April 24, 2017—DiaSorin has received FDA emergency use authorization for the Liaison XL Zika Capture IgM assay, a fully automated …

BloodCenter of Wisconsin’s VWF activity test

April 21, 2017—BloodCenter of Wisconsin, part of Versiti, announced the launch of a new assay that will more accurately measure …

Roche’s histology test gets FDA clearance

April 19, 2017—Roche has received 510(k) clearance from the FDA for the CINtec Histology test. This test, when used in …

Qiagen launches JAK2 test

April 17, 2017—Qiagen launched its Ipsogen JAK2 RGQ PCR Kit, which was cleared by the Food and Drug Administration as …

Philips WSI system FDA OK’d for digital pathology

April 13, 2017—The FDA on April 12 permitted marketing of Royal Philips IntelliSite Pathology Solution (PIPS), the first whole slide imaging …

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