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K Number
K964418
Device Name
N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET
Manufacturer
KAMIYA TECHNOLOGY SERVICES
Date Cleared
1996-12-13

(73 days)

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

§ 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).