HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA

• K Number: K962452
• Device Name: HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA
• Manufacturer: HYCOR BIOMEDICAL, INC.
• Date Cleared: 1996-11-25 ( 160 days)
• Product Code: DBM
• Regulation Number: 866.5090

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 866.5090 Antimitochondrial antibody immunological test system.

(a)
Identification. An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).(b)
Classification. Class II (performance standards).

Summary

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