DAG · Complement C8, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5240 · Class 2
Overview
| Product Code | DAG |
|---|---|
| Device Name | Complement C8, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5240 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
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).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
