DAK · Complement C1q, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5240 · Class 2
Overview
| Product Code | DAK |
|---|---|
| Device Name | Complement C1q, 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 (20 of 28)
Showing 20 most recent of 28 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K031563 | BINDAZYME CLQ CIC EIA KIT | The Binding Site, Ltd. | Sep 10, 2003 | SESE |
| K032254 | IBL C1Q-CIC CIA TEST | Ibl GmbH | Aug 29, 2003 | SESE |
| K012576 | CIC-C1Q EIA | American Laboratory Products Co., Ltd. | Jan 29, 2002 | SESE |
| K973203 | THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES | Sangstat Medical Corp. | Sep 30, 1998 | SESE |
| K972873 | IMMUSTRIP HAMA IGG | Immunomedics, Inc. | Mar 17, 1998 | SESE |
| K951968 | HUMAN C1Q RADIAL IMMUNODIFFUSION KIT | Kent Laboratories, Inc. | May 30, 1995 | SESE |
| K914388 | C1 RID KIT | The Binding Site, Ltd. | Oct 28, 1991 | SESE |
| K882829 | CIRCULATING IMMUNE COMPLEXES CONTROLS | Cytotech, Inc. | Aug 4, 1988 | SESE |
| K860996 | SANASSAY IC TEST | Scientific Sales Intl., Inc. | Mar 30, 1987 | SESE |
| K864312 | IC MICROASSAY | Diamedix Corp. | Jan 9, 1987 | SESE |
| K862649 | CYTOTECH CIC ENZYME IMMUNOASSAY | Cytotech, Inc. | Sep 4, 1986 | SESE |
| K861499 | BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT | Biostar Medical Products, Inc. | Jun 20, 1986 | SESE |
| K853697 | BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT | Biostar Medical Products, Inc. | Dec 16, 1985 | SESE |
| K851202 | GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL | Gilford | Apr 29, 1985 | SESE |
| K844294 | CORDIA IC | Cordis Corp. | Feb 4, 1985 | SESE |
| K833275 | GMP CIQ ELISA TEST KIT | Gamma Medical Products, Inc. | Jun 22, 1984 | SESE |
| K833636 | ORTHO* SERUM ELISA TEST SYSTEM | Ortho Diagnostic Systems, Inc. | Jun 13, 1984 | SESE |
| K841541 | SERUM COMPLEMENT ACTIVITY TEST-SCAT | Collaborative Research, Inc. | Jun 1, 1984 | SESE |
| K823009 | GAMMA CLQ | Gamma Medical Products, Inc. | Nov 5, 1982 | SESE |
| K821949 | ORTHO* ALTERNATIVE PATHWAY COMPL. TEST | Ortho Diagnostic Systems, Inc. | Aug 27, 1982 | SESE |
Top Applicants
- Ortho Diagnostic Systems, Inc. — 3 clearances
- Biostar Medical Products, Inc. — 2 clearances
- Cytotech, Inc. — 2 clearances
- Gamma Medical Products, Inc. — 2 clearances
- Hyland Therapeutic Div., Travenol Laboratories — 2 clearances
