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ELISA HSV-2 IgG Test System

FDA UDI

by Zeus Scientific, Inc.

Identity

Trade Name
ELISA HSV-2 IgG Test System FDA UDI
Generic Name
Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The ZEUS ELISA Herpes Simplex Virus-2 (HSV-2) IgG Test System is an enzyme-linked immunosorbent assays (ELISA) for the qualitative detection of IgG class antibodies to Herpes Simplex Virus (HSV) in human serum. The test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV. Due to cross-reactivity of shared antigens, both tests (HSV-1 and HSV-2 ELISAs) must be run in parallel on the same sample to fully evaluate patient sera. This test is for In Vitro diagnostic use. FDA UDI
Model / Reference
9Z9751G FDA UDI
Description
The ZEUS ELISA Herpes Simplex Virus-2 (HSV-2) IgG Test System is an enzyme-linked immunosorbent assays (ELISA) for the qualitative detection of IgG class antibodies to Herpes Simplex Virus (HSV) in human serum. The test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV. Due to cross-reactivity of shared antigens, both tests (HSV-1 and HSV-2 ELISAs) must be run in parallel on the same sample to fully evaluate patient sera. This test is for In Vitro diagnostic use. FDA UDI

Identifiers

Catalog Number
9Z9751G FDA UDI
Primary DI / UDI-DI
00845533000741 FDA UDI
GMDN Term
Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) 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: Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA HSV-2 IgG Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) 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 fd92adb5-78e3-4a5c-a075-47102e73bd08 35 fields · synced Jun 8, 2026