B. burgdorferi IgG/IgM Test System

Intended Use

The ZEUS IFA Borrelia burgdorferi IgG/IgM Test System is an indirect fluorescent antibody assay intended for the qualitative and semi-quantitative presumptive detection of IgG and IgM antibodies to Borrelia burgdorferi in human serum. This test system should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. This test system is for in vitro diagnostic use.

Registration / Clearance

FDA Cleared

CE Marked