Identity
- Trade Name
- Access Free T4 FDA UDI
- Generic Name
- Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- C76421 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- C76421 FDA UDI
- Primary DI / UDI-DI
- 15099590780982 FDA UDI
- FDA Product Code
- CEC FDA UDI
- GMDN Term
- Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1695 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Access Free T4 by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay.
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- Monobind AccuLite Free T4 CLIA Kit - 960 Wells — MONOBIND, INC. · Class II
- Alinity — ABBOTT IRELAND · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- ADVIA Centaur® FT4 — Siemens Healthcare Diagnostics · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI 46316235-d24f-4f8e-a842-9ebc8e1656c5 34 fields · synced Jun 8, 2026