Parvovirus B19 IgG/IgM
- Primary DI
- 00845533003438
- Brand
- Parvovirus B19 IgG/IgM
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- V119IF
- Catalog number
- V119IF
- Device description
- The Parvovirus B19 Immunofluorescent Assay is intended for the qualitative and semi-quantitative detection of anti-Parvovirus B19 IgG and IgM antibodies in human serum. The test is indicated for use in all women where there is a suspicion of exposure to Parvovirus B19 to determine the presence of a recent or current infection.
- 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 |
|---|---|---|---|---|
| 00845533003438 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00845533003438 | 00845533003438 | 845533003438 | 0845533003438 |
GMDN Terms#
| Term | Definition |
|---|---|
| Parvovirus B19 immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Parvovirus B19 in a clinical specimen, using a fluorescent immunoassay 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
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00845533003551 | Legionella pneumophila (Group 1-6) | FA15001 | FA15001 | 2026-05-26 |
| 00845533003568 | Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG | FA9151G | FA9151G | 2026-05-26 |
| 00845533003575 | Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM | FA9151M | FA9151M | 2026-05-26 |
| 00845533003483 | Striated Muscle (Rat) | 5848RL | 5848RL | 2026-05-15 |
| 00845533003490 | Alegria Flash PR3 | CL28141 | CL28141 | 2026-05-15 |
| 00845533003506 | Alegria Flash PR3 Control Kit | CL28141CK | CL28141CK | 2026-05-15 |
| 00845533003513 | Alegria Flash MPO | CL28131 | CL28131 | 2026-05-15 |
| 00845533003520 | Alegria Flash MPO Control Kit | CL28131CK | CL28131CK | 2026-05-15 |
| 00845533003537 | Alegria Flash GBM | CL28151 | CL28151 | 2026-05-15 |
| 00845533003544 | Alegria Flash GBM Control Kit | CL28151CK | CL28151CK | 2026-05-15 |
| 00845533003476 | Fluorescent Treponemal Antibody-Absorption Titratable (FTA-ABS TT) | FA7001T | FA7001T | 2026-04-15 |
| 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 |