Product code NRX
- Device name
- Complement 4d (C4d) And Complement Receptor 1 (Cr1)
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5820
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset