510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NRXClass II

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

21 CFR 866.5820 / Immunology
FDA source (opens on fda.gov)

NRX is the FDA product code for Complement 4d (C4d) And Complement Receptor 1 (Cr1), a class II device type, regulated under 21 CFR 866.5820. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NRX
Device name
Complement 4d (C4d) And Complement Receptor 1 (Cr1)
FDA 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.
Regulation
21 CFR 866.5820
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NRX.