Identity
- Trade Name
- Total Thyroxine ELISA (Total T4 ELISA) FDA UDI
- Generic Name
- Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Total Thyroxine ELISA (Total T4 ELISA) is intended for use in the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders. FDA UDI
- Model / Reference
- 25-TT4HU-E01 FDA UDI
- Description
- The Total Thyroxine ELISA (Total T4 ELISA) is intended for use in the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders. FDA UDI
Identifiers
- Catalog Number
- 25-TT4HU-E01 FDA UDI
- Primary DI / UDI-DI
- B24225TT4HUE010 FDA UDI
- 510(k) Number
- K991432 FDA UDI
- FDA Product Code
- KLI FDA UDI
- GMDN Term
- Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Category: Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)
Total Thyroxine ELISA (Total T4 ELISA) by American Laboratory Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- American Laboratory Products Company
Sources (1)
- FDA UDI 4d9ea8fd-9199-47a9-8673-d7259ede38af 37 fields · synced May 31, 2026