DAC · Complement C3b Activator, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5260 · Class 2
Overview
| Product Code | DAC |
|---|---|
| Device Name | Complement C3b Activator, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5260 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
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).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K891904 | EZ COMPLEMENT C1 | Diamedix Corp. | Apr 14, 1989 | SESE |
| K771583 | FLUORESCENT ANTI. ANTI-HUMAN C3 | Burroughs Wellcome Co. | Sep 2, 1977 | SESE |
Top Applicants
- Diamedix Corp. — 1 clearance
- Burroughs Wellcome Co. — 1 clearance
