Complement 4d (C4d) And Complement Receptor 1 (Cr1)

NRX · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5820

Classification

FDA Product Code: NRX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.5820
Review panel: IM
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown