This article was originally published in The Gray Sheet
FDA clears 510(k) for the AtheNA Multi-Lyte ANA (anti-nuclear antibody) assay system with active calibration technology based on Luminex' LabMAP technology, firm announces Dec. 19. Luminex will receive royalty payments on sales of the device, which detects nine separate analytes in human serum simultaneously as an aid in diagnosing autoimmune disorders. Zeus will begin marketing the in vitro clinical lab assay in the first quarter of 2002 through a distribution partnership with Wampole Laboratories...
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