DAE · Complement C9, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5240 · Class 2
Overview
| Product Code | DAE |
|---|---|
| Device Name | Complement C9, 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).
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K150412 | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator | The Binding Site Group , Ltd. | Aug 28, 2015 | SESE |
| K113349 | HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO | The Binding Site Group , Ltd. | Jul 11, 2012 | SESE |
| K992488 | TOTAL HAEMOLYTIC COMPLEMENT RID KIT | The Binding Site, Ltd. | Sep 17, 1999 | SESE |
| K974111 | QUIDEL CH50 EQ EIA | Quidel Corp. | Jul 29, 1998 | SESE |
| K954145 | WAKO AUTOKIT CH50 | Wako Chemicals USA, Inc. | Dec 18, 1995 | SESE |
| K951639 | COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) | Incstar Corp. | Oct 13, 1995 | SESE |
Top Applicants
- The Binding Site Group , Ltd. — 2 clearances
- Wako Chemicals USA, Inc. — 1 clearance
- The Binding Site, Ltd. — 1 clearance
- Quidel Corp. — 1 clearance
- Incstar Corp. — 1 clearance
