Rheumatoid Factor Latex-Enhanced Immunoturbidimetric Test Kit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K972220 FDA 510(k)
- FDA Product Code
- DHR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5775 FDA 510(k)
- Regulation Number
- 866.5775 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rheumatoid Factor Latex-Enhanced Immunoturbidimetric Test Kit is an in vitro diagnostic reagent designed for the quantitative determination of rheumatoid factors in human serum. It is used to facilitate the detection and diagnosis of rheumatoid arthritis.
This device is supplied by Randox Laboratories, Ltd. and has received FDA 510(k) clearance. It is intended for laboratory use in the quantitative analysis of rheumatoid factors.
Frequently asked questions
What is the primary clinical purpose of this test kit?
This kit is an in vitro diagnostic reagent used for the quantitative analysis of rheumatoid factors in human serum. It is specifically intended to facilitate the detection and clinical diagnosis of rheumatoid arthritis.
Who is the manufacturer of this diagnostic reagent?
This device is manufactured by Randox Laboratories, Ltd., located in Crumlin, Co. Antrim, Ireland.
Has this device received regulatory clearance?
Yes, the Rheumatoid Factor Latex-Enhanced Immunoturbidimetric Test Kit has received FDA 510(k) clearance under the K972220 submission, which determined the device to be substantially equivalent to existing systems.
Is this kit intended for home use?
No, this device is intended for laboratory use only. It is designed as an in vitro diagnostic reagent for professional quantitative analysis within a clinical or laboratory setting.
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: Rheumatoid Factor Latex-enhanced Immunoturbidimetric Test Kit (K972220 ..., Rheumatoid Factor - Randox Laboratories, Rheumatoid Factor | Reagent | Randox Laboratories
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K972220 | Class II | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA 510(k) K972220 24 fields · synced Sep 27, 2026