WAKO AUTOKIT C4
Device Facts
| Record ID | K010325 |
|---|---|
| Device Name | WAKO AUTOKIT C4 |
| Applicant | Wako Chemicals USA, Inc. |
| Product Code | DBI · Immunology |
| Decision Date | Jun 25, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5240 |
| Device Class | Class 2 |
Regulatory Classification
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.
