21 CFR 866.5260 — Complement C3b Activator, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5260
Identification
A complement C3b inactivator immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C3b inactivator (a plasma protein) in serum. Complement is a group of serum proteins that destroy infectious agents. Measurement of complement C3b inactivator aids in the diagnosis of inherited antibody dysfunction.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DAC | Complement C3b Activator, Antigen, Antiserum, Control | 2 | 2 | 3rd Party |
| KTP | Complement C3b Activator Immunoassay Reagents | 2 | 1 | 3rd Party |
