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The digital pathology system can be used for primary diagnosis as a result of the 510(k) clearance, which followed a multicenter study conducted at five clinical sites.
The immunoassays are are indicated for the quantitative determination of IgM RF antibodies and the semi-quantitative determination of IgA RF antibodies.
The Aptima BV test detects bacterial vaginosis and the Aptima CV/TV detects and differentiates candida infections from trichomonas.
The agency said that it is the first diagnostic test for detecting Zika virus immunoglobulin (IgM) antibodies that it has allowed to be marketed in the US.
The Hologic Aptima Combo 2 and the Cepheid Xpert CT/NG assays have now been cleared for use in throat and rectum samples.
The QiaStat-Dx system will now be commercially available in the US along with a panel that detects more than 20 respiratory viral and bacterial pathogens.
GenMark Diagnostics received clearance for a third BCID panel that the firm said paves the way for a customizable approach to sepsis MDx.
The firm said that its new hematology-based cellular biomarker test has the potential to advance clinicians’ approach to sepsis triage and diagnosis.
The firm said that its Vitros XT MicroSlides improve lab turnaround time by delivering simultaneous results for pairs of tests that physicians frequently order.
Designed for small and medium-sized labs, the system offers automated blood typing and screening based on gel card technology with minimum user intervention.