REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT

• K Number: K001352
• Device Name: REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
• Manufacturer: CORGENIX, INC.
• Date Cleared: 2001-04-09 ( 346 days)
• Product Code: DHC
• Regulation Number: 866.5820

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

§ 866.5820 Systemic lupus erythematosus immunological test system.

(a)
Identification. A systemic lupus erythematosus (SLE) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum and other body fluids that react with cellular nuclear double-stranded deoxyribonucleic acid (DNA) or other nuclear constituents that are specifically diagnostic of SLE. Measurement of nuclear double-stranded DNA antibodies aids in the diagnosis of SLE (a multisystem autoimmune disease in which tissues are attacked by the person's own antibodies).(b)
Classification. Class II (performance standards).

Summary

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