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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)
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