21 CFR 866.5240 — Complement C3, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5240
Identification
A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CZW | Complement C3, Antigen, Antiserum, Control | 2 | 44 | 3rd Party |
| CZY | Complement C1s, Antigen, Antiserum, Control | 2 | 1 | 3rd Party |
| DAE | Complement C9, Antigen, Antiserum, Control | 2 | 6 | 3rd Party |
| DAG | Complement C8, Antigen, Antiserum, Control | 2 | 0 | 3rd Party |
| DAI | Complement C1r, Antigen, Antiserum, Control | 2 | 0 | 3rd Party |
| DAK | Complement C1q, Antigen, Antiserum, Control | 2 | 28 | 3rd Party |
| DAY | Complement C5, Antigen, Antiserum, Control | 2 | 3 | 3rd Party |
| DBI | Complement C4, Antigen, Antiserum, Control | 2 | 34 | 3rd Party |
| KTM | C3-Indirect Immunofluorescent Solid Phase | 2 | 0 | 3rd Party |
