Identity
- Trade Name
- Total Triiodothyronine T3 ELISA (Total T3 ELISA) FDA UDI
- Generic Name
- Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Total Triiodothyronine T3 ELISA (Total T3 ELISA) is intended for use in the quantitative determination of triiodothyronine (T3) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid diseases such as hyperthyroidism. FDA UDI
- Model / Reference
- 25-TRIHU-E01 FDA UDI
- Description
- The Total Triiodothyronine T3 ELISA (Total T3 ELISA) is intended for use in the quantitative determination of triiodothyronine (T3) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid diseases such as hyperthyroidism. FDA UDI
Identifiers
- Catalog Number
- 25-TRIHU-E01 FDA UDI
- Primary DI / UDI-DI
- B24225TRIHUE010 FDA UDI
- FDA Product Code
- CDP FDA UDI
- GMDN Term
- Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1710 FDA UDI
- Commercial Distribution
- Not 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
Total Triiodothyronine T3 ELISA (Total T3 ELISA) by American Laboratory Products Company — Class II — FDA UDI — listed in FDA GUDID
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 13eddf2b-931d-4d44-9853-2cdd1da01995 37 fields · synced May 30, 2026