Anti-HSV-1 & 2 IgM
- Primary DI
- 00845533003247
- Brand
- Anti-HSV-1 & 2 IgM
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- 9Z9771M
- Catalog number
- 9Z9771M
- Device description
- The Anti-HSV-1 & 2 IgM is an enzyme-linked immunosorbent assay for the qualitative detection of IgM class antibodies to Herpes Simplex Virus (HSV) in human serum. This test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV and is for In Vitro diagnostic use.
- 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 |
|---|---|---|---|---|
| 00845533003247 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00845533003247 | 00845533003247 | 845533003247 | 0845533003247 |
GMDN Terms#
| Term | Definition |
|---|---|
| Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) 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 M (IgM) antibodies to herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) 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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|---|---|---|---|---|
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| 00845533003520 | Alegria Flash MPO Control Kit | CL28131CK | CL28131CK | 2026-05-15 |
| 00845533003537 | Alegria Flash GBM | CL28151 | CL28151 | 2026-05-15 |
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| 00845533002851 | Anti-SARS-CoV-2 IgG | SM9Z7901G | SM9Z7901G | 2026-04-01 |
| 00845533002868 | Anti-SARS-CoV-2 Total | SM9Z7901 | SM9Z7901 | 2026-04-01 |
| 00845533003100 | Anti-dsDNA | 2Z2881G | 2Z2881G | 2026-04-01 |
| 00845533003117 | Anti-dsDNA | SM2Z2881G | SM2Z2881G | 2026-04-01 |
| 00845533003124 | Anti-EBV EA IgG | 9Z9481G | 9Z9481G | 2026-04-01 |
| 00845533003131 | Anti-EBV EA IgG | SM9Z9481G | SM9Z9481G | 2026-04-01 |
| 00845533003148 | ENA Screen | 2Z2851G | 2Z2851G | 2026-04-01 |
| 00845533003155 | ENA Screen | SM2Z2851G | SM2Z2851G | 2026-04-01 |
| 00845533003162 | Anti-Gliadin IgA | 2Z61001A | 2Z61001A | 2026-04-01 |