N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET

• 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: Immunology
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 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).