Identity
- Trade Name
- Total Triiodothyronine (Total T3) ELISA FDA UDI
- Generic Name
- Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Total Triiodothyronine (Total T3) ELISA Kit is intended for the quantitative determination of total triiodothyronine (T3) concentration in human serum and plasma. FDA UDI
- Model / Reference
- 20-TT3HU-E01 FDA UDI
- Description
- The Total Triiodothyronine (Total T3) ELISA Kit is intended for the quantitative determination of total triiodothyronine (T3) concentration in human serum and plasma. FDA UDI
Identifiers
- Catalog Number
- 20-TT3HU-E01 FDA UDI
- Primary DI / UDI-DI
- B24220TT3HUE011 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
- 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
Yes
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 triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA)
Total Triiodothyronine (Total T3) ELISA by American Laboratory Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 07b7231f-9ed1-4c2f-a9f4-fdb684a0e5e1 36 fields · synced May 31, 2026