Rheumacol Rheumatoid Factor Test
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K972456 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 Rheumacol Rheumatoid Factor Test is a rapid, color-enhanced hemagglutination slide test that detects rheumatoid factor in human serum samples. It is used to aid clinicians in diagnosing rheumatoid arthritis. The test provides a qualitative result and is designed for professional use in clinical laboratory settings.
The test is supplied as a kit and involves mixing patient serum with the test reagent on a slide. It is intended for single-use and is regulated under FDA 510(k) with the clearance type being Traditional. The device has a product code of DHR and a regulation number of 866.5775.
Frequently asked questions
What is the Rheumacol Rheumatoid Factor Test used for?
The Rheumacol Rheumatoid Factor Test is used to aid clinicians in diagnosing rheumatoid arthritis by detecting rheumatoid factor in human serum samples.
How is the test supplied and used?
The test is supplied as a kit and involves mixing patient serum with the test reagent on a slide, providing a qualitative result.
Is the Rheumacol Rheumatoid Factor Test for single-use or reuse?
The Rheumacol Rheumatoid Factor Test is intended for single-use.
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: RHEUMACOL RHEUMATOID FACTOR TEST (K972456) — FDA 510 (k) | Innolitics, fda.innolitics.com, Rheumacol™ RF Test Kit - Rapid Rheumatoid Detection
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K972456 | Class II | Active |
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Manufacturer
- Manufacturer
- Immunostics Inc.,
Sources (1)
- FDA 510(k) K972456 24 fields · synced Sep 21, 2026