ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35

• K Number: K083868
• Device Name: ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
• Manufacturer: AXIS-SHIELD DIAGNOSTICS, LTD.
• Date Cleared: 2009-09-25 ( 270 days)
• Product Code: NHX , JIX , JJY
• Regulation Number: 866.5775
• Type: Traditional
• Panel: Immunology
• Reference & Predicate Devices: N/A
• Predicate For: K153551

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).