AtheNA Multi-Lyte® TPO/Tg IgG Plus Test System
- Primary DI
- 00845533000109
- Brand
- AtheNA Multi-Lyte® TPO/Tg IgG Plus Test System
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- A51101
- Catalog number
- A51101
- Device description
- The ZEUS AtheNA Multi-Lyte® TPO/Tg Plus Test System is intended for the quantitative detection of IgG class antibody to 2 separate Thyroid Antigens; Thyroid Peroxidase (TPO) and Thyroglobulin (Tg), in human serum. The test system is intended to be used as an aid in the diagnosis of various autoimmune thyroid diseases. This test is for In Vitro diagnostic use only.
- Published
- 2016-09-24
- Public version status
- Update
- 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 |
|---|---|---|---|---|
| 00845533000109 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00845533000109 | 00845533000109 | 845533000109 | 0845533000109 |
GMDN Terms#
| Term | Definition |
|---|---|
| Thyroglobulin/Thyroid peroxidase antibody (anti-TPO/Microsomal 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 antibodies to both thyroglobulin and thyroid peroxidase (anti-TPO; also known as anti-microsomal antibody) 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
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
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