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

§ 866.5820 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).