KTP · Complement C3b Activator Immunoassay Reagents
Immunology · 21 CFR 866.5260 · Class 2
Overview
| Product Code | KTP |
|---|---|
| Device Name | Complement C3b Activator Immunoassay Reagents |
| 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K790059 | PROACTIVATOR C3, C4 AND C3 | Icl Scientific | Mar 15, 1979 | SESE |
Top Applicants
- Icl Scientific — 1 clearance
