CZW · Complement C3, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5240 · Class 2
Overview
| Product Code | CZW |
|---|---|
| Device Name | Complement C3, 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 44)
Showing 20 most recent of 44 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K100179 | SPAPLUS | The Binding Site Group , Ltd. | Aug 13, 2010 | SESE |
| K063150 | COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL | Thermo Electron OY | Mar 19, 2007 | SESE |
| K061852 | DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH | Dade Behring, Inc. | Sep 22, 2006 | SESE |
| K050665 | N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) | Dade Behring, Inc. | May 2, 2005 | SESE |
| K042494 | VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III | Ortho-Clinical Diagnostics | Oct 19, 2004 | SESE |
| K032796 | IBL C3D-CIC EIA TEST | Ibl GmbH | Jan 13, 2004 | SESE |
| K032035 | SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI | Beckman Coulter, Inc. | Aug 7, 2003 | SESE |
| K012361 | TINA-QUANT COMPLEMENT C3C TEST SYSTEM | Roche Diagnostics Corp. | Nov 29, 2001 | SESE |
| K010326 | WAKO AUTOKIT C3 | Wako Chemicals USA, Inc. | Jun 25, 2001 | SESE |
| K000469 | RANDOX COMPLEMENT C3 | Randox Laboratories, Ltd. | Mar 27, 2000 | SESE |
| K994296 | DIMENSION C3 FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Mar 1, 2000 | SESE |
| K981783 | C3 MININEPH ANTISERUM | The Binding Site, Ltd. | Dec 20, 1999 | SESE |
| K993437 | K-ASSAY C3 | Kamiya Biomedical Co. | Nov 24, 1999 | SESE |
| K991907 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | Bayer Corp. | Nov 9, 1999 | SESE |
| K983441 | C3 | Abbott Laboratories | Nov 4, 1998 | SESE |
| K964298 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | Jul 14, 1997 | SESE |
| K964842 | IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT | Beckman Instruments, Inc. | Jun 11, 1997 | SESE |
| K962409 | OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT | Olympus America, Inc. | Oct 18, 1996 | SESE |
| K962199 | QUANTEX C3 | Instrumentation Laboratory CO | Sep 25, 1996 | SESE |
| K955857 | N PROTEIN STANDARS SY | Behring Diagnostics, Inc. | Feb 21, 1996 | SESE |
Top Applicants
- Dako Corp. — 3 clearances
- Dade Behring, Inc. — 3 clearances
- The Binding Site, Ltd. — 2 clearances
- Instrumentation Laboratory CO — 2 clearances
- Diamedix Corp. — 2 clearances
