ELISA VZV IgG Smart Kit Test System
- Primary DI
- 00845533001298
- Brand
- ELISA VZV IgG Smart Kit Test System
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- SM9Z9331G
- Catalog number
- SM9Z9331G
- Device description
- The ZEUS ELISA Varicella-Zoster Virus (VZV) IgG Test System is intended for the qualitative detection of VZV IgG antibody in human serum. When performed according to these instructions, the results of this test, together with other clinical information, may aid in the determination of immune status, and/or aid in the diagnosis of VZV infections. This test is intended for In Vitro diagnostic use.
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00845533001298 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00845533001298 | 00845533001298 | 845533001298 | 0845533001298 |
GMDN Terms#
| Term | Definition |
|---|---|
| Varicella-zoster virus (VZV) 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 varicella-zoster virus (VZV) 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 |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 080953946
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|---|---|---|---|
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| 00845533003575 | Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM | FA9151M | FA9151M | 2026-05-26 |
| 00845533003087 | Anti-M. pneumoniae IgM | Q3Z17601MB | Q3Z17601MB | 2026-03-12 |
| 00845533003094 | Anti-VZV IgM | 9Z9331MB | 9Z9331MB | 2026-03-12 |
| 00845533003063 | Alegria Flash ENA Screen | CL28051 | CL28051 | 2026-02-19 |
| 00845533003070 | Alegria Flash ENA Screen Control Kit | CL28051CK | CL28051CK | 2026-02-19 |
| 00845533002882 | Cardiac Muscle (Rat) | 5448RL | 5448RL | 2026-02-18 |
| 00845533002899 | Adrenal Cortex (Primate) | 6448L | 6448L | 2026-02-18 |
| 00845533002905 | Ovary (Primate) | 6648L | 6648L | 2026-02-18 |
| 00845533002912 | Testes (Primate) | 6748L | 6748L | 2026-02-18 |
| 00845533002929 | Mumps Virus IgG | I-MUV01G | I-MUV01G | 2026-02-18 |
| 00845533002936 | NTx Urine | NTx9006 | 2026-02-18 | |
| 00845533002943 | NTx Serum | NTx9021 | NTx9021 | 2026-02-18 |
| 00845533002950 | Anti-Borrelia VlsE1/pepC10 IgG/IgM | PF-SM3Z9661 | PF-SM3Z9661 | 2026-02-18 |
| 00845533002967 | ANA Screen | 2Z29001G | 2Z29001G | 2026-02-18 |
| 00845533002974 | ANA Screen | SM2Z29001G | SM2Z29001G | 2026-02-18 |
| 00845533002981 | ANCA Screen | 2Z9681G | 2Z9681G | 2026-02-18 |
| 00845533002998 | ANCA Screen | SM2Z9681G | SM2Z9681G | 2026-02-18 |
| 00845533003001 | Anti-Cardiolipin IgA | 2Z51051A | 2Z51051A | 2026-02-18 |