Identifiers
- 510(k) Number
- K771220 FDA 510(k)
- FDA Product Code
- CDP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1710 FDA 510(k)
- Regulation Number
- 862.1710 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The T3 RIA TEST SYSTEM is a radioimmunoassay device used for measuring total triiodothyronine (T3) levels. This device is classified under clinical chemistry and is designed for laboratory use in diagnostic testing.
The system is manufactured by Monobind, Inc. and is authorized under FDA 510(k) clearance with product code CDP. It is supplied as a test system and is intended for single-use in laboratory settings. The device is not indicated for MRI use and should be stored according to manufacturer instructions.
Frequently asked questions
What is the T3 RIA TEST SYSTEM used for?
The T3 RIA TEST SYSTEM is a radioimmunoassay device designed for laboratory use in measuring total triiodothyronine (T3) levels, which is important for thyroid function assessment in clinical chemistry diagnostics.
How is the T3 RIA TEST SYSTEM supplied and can it be reused?
The system is supplied as a test system and is intended for single-use in laboratory settings. It should not be reused according to manufacturer instructions to ensure accurate test results and patient safety.
What is the regulatory status of the T3 RIA TEST SYSTEM?
The T3 RIA TEST SYSTEM is authorized under FDA 510(k) clearance with product code CDP, classified under clinical chemistry, and is manufactured by Monobind, Inc. It is not indicated for MRI use.
How should the T3 RIA TEST SYSTEM be stored?
The device should be stored according to the manufacturer's instructions to maintain its integrity and functionality. Specific storage conditions are not detailed in the provided information.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: T3 RIA TEST SYSTEM (K771220) — FDA 510 (k) | Innolitics, PDF K771220 T3 RIA TEST SYSTEM - 510kdatabase.net, MONOBIND, INC. 8125-300A T3 SBS AccuBind ELISA Test System - 96 Wells, Monobind Coated Tube RIA Test System (5572) - Triiodothyronine (T3)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K771220 | Class II | Active |
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Manufacturer
- Manufacturer
- Monobind, Inc.
- FDA Applicant
- Monobind
Sources (1)
- FDA 510(k) K771220 24 fields · synced Sep 27, 2026