Anti-HSV gG-2 IgG
- Primary DI
- 00845533003230
- Brand
- Anti-HSV gG-2 IgG
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- SM9Z9781G
- Catalog number
- SM9Z9781G
- Device description
- The Anti-HSV gG-2 IgG is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The assay is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
- Published
- 2026-04-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00845533003230 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00845533003230 | 00845533003230 | 845533003230 | 0845533003230 |
GMDN Terms#
| Term | Definition |
|---|---|
| Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to herpes simplex virus 2 (HSV2) in a clinical specimen, using an enzyme immunoassay (EIA) method. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Regulatory Flags#
- DUNS number
- 080953946
- Device count
- 1
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
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| 00845533002868 | Anti-SARS-CoV-2 Total | SM9Z7901 | SM9Z7901 | 2026-04-01 |
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| 00845533003155 | ENA Screen | SM2Z2851G | SM2Z2851G | 2026-04-01 |
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