Rheumatoid Factor (rf) Reagenti A Latex Slide Test
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K962015 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)
Rheumatoid Factor (RF) Reagent A Latex Slide Test is a system test for rheumatoid factor used in immunology. It is intended for the qualitative and semi-quantitative measurement of rheumatoid factor in human serum.
The reagent is supplied for use in laboratory settings and is used with human serum specimens. It is regulated under FDA 510(k) clearance (K962015) and classified as a Class II device under regulation number 866.5775. Storage and handling instructions are provided in the manufacturer's labeling.
Frequently asked questions
What is the Rheumatoid Factor RF Reagent A Latex Slide Test used for?
The Rheumatoid Factor (RF) Reagent A Latex Slide Test is intended for the qualitative and semi-quantitative measurement of rheumatoid factor in human serum, used in immunology testing within laboratory settings.
How is the Rheumatoid Factor RF Reagent A Latex Slide Test supplied and what specimen type is required?
The reagent is supplied for use in laboratory settings and requires human serum specimens for testing, as specified in the manufacturer's labeling for proper handling and use.
Is the Rheumatoid Factor RF Reagent A Latex Slide Test sterile or single-use, and how should it be stored?
The device data does not specify sterility or single-use status; however, storage and handling instructions are provided in the manufacturer's labeling, which should be followed to maintain reagent integrity.
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 (RF) - Teco Diagnostics, Serology - Teco Diagnostics, PDF TECO DIAGNOSTICS - Core Lab Supplies, RF Procedure | PDF | Reagent | Serum (Blood)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K962015 | Class II | Active |
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Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA 510(k) K962015 24 fields · synced Oct 1, 2026