Identity
- Trade Name
- Pointe Scientific, Inc. FDA UDI
- Generic Name
- Free thyroxine (FT4) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Free T4 for the quantitative determination of Free Thyroxine (fT4) concentration in human serum. FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES. 96 Tests. FDA UDI
- Model / Reference
- T1008-96 FDA UDI
- Description
- Free T4 for the quantitative determination of Free Thyroxine (fT4) concentration in human serum. FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES. 96 Tests. FDA UDI
Identifiers
- Catalog Number
- T1008-96 FDA UDI
- Primary DI / UDI-DI
- 00811727013156 FDA UDI
- 510(k) Number
- K020548 FDA UDI
- FDA Product Code
- CEC FDA UDI
- GMDN Term
- Free thyroxine (FT4) IVD, kit, enzyme immunoassay (EIA) 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
No
FDA UDI
Category: Free thyroxine (FT4) IVD, kit, enzyme immunoassay (EIA)
Pointe Scientific, Inc. by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Free thyroxine (FT4) IVD, kit, enzyme immunoassay (EIA).
- Free T4 AccuBind ELISA Test System - 960 Wells — MONOBIND, INC. · Class II
- Free T4 AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class II
- Free Thyroxine (fT4) ELISA — DRG International, Inc. · Class II
- Monobind AccuBind Free T4 ELISA Kit - 480 Wells — MONOBIND, INC. · Class II
- Free Thyroxine (fT4) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge FT4 — Siemens Healthcare Diagnostics · Class II
- Free Thyroxine (fT4) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Free Thyroxine (fT4) ELISA — DRG International, Inc. · Class II
Cleared under the same submission
K020548 also covers:
- Free Thyroxine (fT4) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
- Free T4 AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.
- Free T4 AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.
- Free T4 AccuBind ELISA Test System - 960 Wells — MONOBIND, INC.
- Monobind AccuBind Free T4 ELISA Kit - 480 Wells — MONOBIND, INC.
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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 6cf6c983-4f7f-4f3e-9fd5-442c26b7ad6f 37 fields · synced Jun 8, 2026