510(k) Premarket Notification

510(k) Premarket Notification

EUA updates Third Zika diagnostic cleared

October 28, 2019: FDA cleared the LIAISON XL Zika Capture IgM Assay II for the presumptive qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting the CDC Zika virus clinical and/or epidemiological criteria. Previously, the test had been authorized only for emergency use under FDA’s Emergency Use Authorization (EUA) authority. FDA revoked the EUA for the LIAISON XL Zika Capture IgM Assay II test, initially issued on April 5, 2017. Related links: EUA Termination or Revocation Emergency Use Authorization--Archived Information Zika Virus Response Updates from FDA