Designed for exclusive use under an Emergency Use Authorization (EUA) to ensure rapid response to the pandemic: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.
Eligible for operation in CLIA-certified labs capable of conducting moderate or high complexity tests, adhering to stringent quality standards.
Utilizes the advanced ELFA (Enzyme Linked Fluorescent Assay) technology for automated, reliable detection of SARS-COV-2 IgG antibodies, indicating past infection and potential immunity.
Part of the trusted VIDAS® family, offering seamless integration with VIDAS instruments for efficient workflow in clinical laboratories.
