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K Number
K002609
Device Name
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
Manufacturer
ROCHE DIAGNOSTICS CORP.
Date Cleared
2000-09-05

(14 days)

Product Code
DHR
Regulation Number
866.5775
Type
Traditional
Panel
Immunology
Reference & Predicate Devices
N/A
Predicate For
K024067,K032535
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 866.5775 Rheumatoid factor immunological test system.

(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).