← Back to catalogue

ZEUS ELISA VZV IgM 480 Test System

FDA UDI

by Zeus Scientific, Inc.

Identity

Trade Name
ZEUS ELISA VZV IgM 480 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 inhuman sera as an aid in the diagnosis of primary infection or reactivation. The assay performance in detecting antibodies to VZVin 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 bloodand neonates has not been established. FDA UDI
Model / Reference
9Z9331MB FDA UDI
Description
The ZEUS ELISA Varicella-Zoster Virus (VZV) IgM Test System is intended for the qualitative detection of VZV IgM antibody inhuman sera as an aid in the diagnosis of primary infection or reactivation. The assay performance in detecting antibodies to VZVin 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 bloodand neonates has not been established. FDA UDI

Identifiers

Catalog Number
9Z9331MB FDA UDI
Primary DI / UDI-DI
00845533001885 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)

ZEUS ELISA VZV IgM 480 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Zeus Scientific, Inc.

Sources (1)

  • FDA UDI 262ef954-ca0f-448d-b898-81052f2faf90 35 fields · synced May 30, 2026