EZ COMPLEMENT C1
Device Facts
| Record ID | K891904 |
|---|---|
| Device Name | EZ COMPLEMENT C1 |
| Applicant | Diamedix Corp. |
| Product Code | DAC · Immunology |
| Decision Date | Apr 14, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5260 |
| Device Class | Class 2 |
Regulatory Classification
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.
