ELISA Borrelia VlsE1/pepC10 IgG/IgM Smart Kit Test System

Primary DI

00845533001854

Brand

ELISA Borrelia VlsE1/pepC10 IgG/IgM Smart Kit Test System

Company

ZEUS SCIENTIFIC, INC.

Model

PF-SM3Z9661

Catalog number

PF-SM3Z9661

Device description

The ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This assay is for In Vitro diagnostic use.

Published

2022-04-27

Public version status

New

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

true

Single use

true