IFA EBV-NA IgG Test System
- Primary DI
- 00845533001625
- Brand
- IFA EBV-NA IgG Test System
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- FA9153
- Catalog number
- FA9153
- Device description
- The ZEUS IFA Epstein-Barr Virus Nuclear Antigen (EBV-NA) anti-complement immunofluorescence (ACIF) Test System is a relatively rapid and sensitive method for the qualitative and semi-quantitative detection of antibodies to the nuclear antigen of Epstein-Barr virus in human sera. When performed according to instructions, this assay can provide information on infectious mononucleosis (IM) that may be of value in patient management and treatment. This device is 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 |
|---|
| 00845533001625 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00845533001625 | 00845533001625 | 845533001625 | 0845533001625 |
GMDN Terms
| Term | Definition |
|---|
| Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) 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) antibodies to the Epstein-Barr virus nuclear antigen (EBNA) of Epstein-Barr virus (EBV) in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
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
- true
- No natural rubber latex
- false
- Sterilization required before use
- false
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