DAY · Complement C5, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5240 · Class 2
Overview
| Product Code | DAY |
|---|---|
| Device Name | Complement C5, 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).
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K942326 | HUMAN C5 RID KITS | Jay H. Geller | Aug 24, 1995 | SESE |
| K950102 | HUMAN C-5 RADIAL IMMUNODIFFUSION KIT | Kent Laboratories, Inc. | Apr 10, 1995 | SESE |
| K772075 | RADIAL IMMUNODIFFUSION KIT-COMPLEMENT | Gelman Instrument Co. | Feb 3, 1978 | SESE |
Top Applicants
- Kent Laboratories, Inc. — 1 clearance
- Jay H. Geller — 1 clearance
- Gelman Instrument Co. — 1 clearance
