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ELISA VZV IgM Test System

FDA UDI

by Zeus Scientific, Inc.

Identity

Trade Name
ELISA VZV IgM Test System FDA UDI
Generic Name
Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
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. FDA UDI
Model / Reference
9Z9331M FDA UDI
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. FDA UDI

Identifiers

Catalog Number
9Z9331M FDA UDI
Primary DI / UDI-DI
00845533001304 FDA UDI
GMDN Term
Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA VZV IgM Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zeus Scientific, Inc.

Sources (1)

  • FDA UDI 997caa9e-b1a0-4a2a-b06c-02b3d3dbc5d7 35 fields · synced Jun 8, 2026