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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device complement 4d (c4d) and complement receptor 1 (cr1)
Regulation Description Systemic lupus erythematosus immunological test system.
Definition The device is an indirect immunofluorescence assay utilizing monoclonal antibodies and flow cytometry in the quantitative determination of complement 4d (C4d) and complement receptor 1 (CR1) on the surface of erythrocytes from EDTA anti-coagulated whole blood. The C4d and CR1 results are used in a ratio as an aid in the diagnosis of systemic lupus erythematosus.
Product CodeNRX
Regulation Number 866.5820
Device Class 2

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