Access Total T4
- Primary DI
- 15099590225742
- Brand
- Access Total T4
- Company
- Beckman Coulter, Inc.
- Model
- 33800
- Catalog number
- 33800
- Device description
- The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels i
- Published
- 2016-09-09
- 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
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | Clinical Chemistry | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 15099590225742 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 15099590225742 | 15099590225742 |
GMDN Terms
| Term | Definition |
|---|---|
| Thyroxine binding capacity IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroxine binding capacity of a clinical specimen, using a chemiluminescent immunoassay method. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 008254708
- 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
- true
- 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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| 04048474041095 | Free Thyroxine (fT4) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | KLI | 2023-08-31 |
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