FDA UDI
In Commercial Distribution
🇺🇸 United States
Access Free T4
DI: 15099590780982
·
Model: C76421
·
Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Access Free T4
- Primary DI
- 15099590780982
- Version / Model
- C76421
- Catalog Number
- C76421
- Company Name
- Beckman Coulter, Inc.
- Labeler DUNS
- 008254708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-12
- Public Version
- 1
- Public Version Date
- 2024-03-20
- Public Version Status
- New
- Public Device Record Key
- 46316235-d24f-4f8e-a842-9ebc8e1656c5
Device Description
The Access Free T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) for the diagnosis and treatment of thyroid diseases using the Access Immunoassay Systems.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CEC | Radioimmunoassay, Free Thyroxine | Clinical Chemistry | 862.1695 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54413 | Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the quantitative measurement of free thyroxine (FT4) in a clinical specimen, using a chemiluminescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15099590780982 | GS1 |