IFA CMV IgG Test System
- Primary DI
- 00845533001533
- Brand
- IFA CMV IgG Test System
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- FA9001G
- Catalog number
- FA9001G
- Device description
- The ZEUS IFA Cytomegalovirus (CMV) IgG Test System is designed for the qualitative and semi-quantitative detection of anti-CMV IgG antibody in human serum by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
- 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
Related Records
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00845533001533 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00845533001533 | 00845533001533 | 845533001533 | 0845533001533 |
GMDN Terms
| Term | Definition |
|---|---|
| Cytomegalovirus (CMV) 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 cytomegalovirus (CMV) 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 |
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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