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ELISA B. burgdorferi IgG/IgM Smart Kit Test System
ZEUS SCIENTIFIC, INC. · Model SM3Z9651 · UDI-DI 00845533000239
Prescription
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510(k) clearances
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Adverse events
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Facilities
Description
The ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of total (IgG and IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA 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.
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