ELISA VZV IgM Smart Kit Test System

Primary DI

00845533001328

Brand

ELISA VZV IgM Smart Kit Test System

Company

ZEUS SCIENTIFIC, INC.

Model

SM9Z9331M

Catalog number

SM9Z9331M

Device description

The ZEUS ELISA Varicella-Zoster Virus (VZV) IgM Test System is intended for the qualitative detection of VZV IgM antibody in human sera as an aid in the diagnosis of primary infection or reactivation. The assay performance in detecting antibodies to VZV in individuals vaccinated with the FDA licensed VZV vaccine is unknown. The user of this assay is responsible for establishing the performance characteristics with VZV vaccinated individuals. The assay performance in detecting antibodies to VZV in cord blood and neonates has not been established.

Published

2016-09-24

Public version status

Update

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

true

OTC

false

Sterile

false

Single use

true