NRX — Complement 4d (C4d) And Complement Receptor 1 (Cr1) Class II
FDA product code NRX covers "Complement 4d (C4d) And Complement Receptor 1 (Cr1)", a Class II medical device regulated under 21 CFR 866.5820. Submissions are reviewed by the Immunology panel.
Classification Details
- Product Code
- NRX
- Device Class
- Class II
- Regulation Number
- 866.5820
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
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.