Complement C3, Antigen, Antiserum, Control
FDA product code CZW · Class II (moderate risk) · 21 CFR 866.5240 · Immunology
44510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Dade Behring, Inc. 3
- Dako Corp. 3
- Behring Diagnostics, Inc. 2
- Instrumentation Laboratory CO 2
- The Binding Site, Ltd. 2
- Diamedix Corp. 2
- Cooper Biomedical, Inc. 1
- The Binding Site Group , Ltd. 1
- Kallestad Diag, A Div. of Erbamont, Inc. 1
- Boehringer Mannheim Corp. 1
- Immunomedics, Inc. 1
- Gilford 1
- Oxford Laboratories, Inc. 1
- Applications Lab 1
- Technicon Instruments Corp. 1
- Intl. Diagnostic Technology 1
- Scripps-Miles, Inc. 1
- J.T. Baker Chemical Co. 1
- Calbiochem-Behring Corp. 1
- Sherwood Medical Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100179 | SpaplusCZW · Traditional | The Binding Site Group , Ltd. | 08/13/2010SE |
| K063150 | Complement C3 and C4, Specical Calibrator and Specitrol Control and High ControlCZW · Traditional | Thermo Electron OY | 03/19/2007SE |
| K061852 | Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low…CZW · Traditional | Dade Behring, Inc. | 09/22/2006SE |
| K050665 | N Antisera to Human Complement Factors (C3C, C4)CZW · Traditional | Dade Behring, Inc. | 05/02/2005SE |
| K042494 | Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance…CZW · Traditional | Ortho-Clinical Diagnostics | 10/19/2004SE |
| K032796 | Ibl C3D-CIC Eia TestCZW · Traditional | Ibl GmbH | 01/13/2004SE |
| K032035 | Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4)…CZW · Traditional | Beckman Coulter, Inc. | 08/07/2003SE |
| K012361 | Tina-Quant Complement C3C Test SystemCZW · Traditional | Roche Diagnostics Corp. | 11/29/2001SE |
| K010326 | Wako Autokit C3CZW · Traditional | Wako Chemicals USA, Inc. | 06/25/2001SE |
| K000469 | Randox Complement C3CZW · Traditional | Randox Laboratories, Ltd. | 03/27/2000SE |
| K994296 | Dimension C3 Flex Reagent CartridgeCZW · Traditional | Dade Behring, Inc. | 03/01/2000SE |
| K981783 | C3 Minineph AntiserumCZW · Traditional | The Binding Site, Ltd. | 12/20/1999SE |
| K993437 | K-Assay C3CZW · Traditional | Kamiya Biomedical Co. | 11/24/1999SE |
| K991907 | Additional Ims Assays for the Bayer Advia Ims SystemCZW · Traditional | Bayer Corp. | 11/09/1999SE |
| K983441 | C3CZW · Traditional | Abbott Laboratories | 11/04/1998SE |
| K964298 | N-Assay Tia Multi V-NlCZW · Traditional | Crestat Diagnostics, Inc. | 07/14/1997SE |
| K964842 | Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4 (C4) ReagentCZW · Traditional | Beckman Instruments, Inc. | 06/11/1997SE |
| K962409 | Olympus C3 Immunoturbidimetric RegentCZW · Traditional | Olympus America, Inc. | 10/18/1996SE |
| K962199 | Quantex C3CZW · Traditional | Instrumentation Laboratory CO | 09/25/1996SE |
| K955857 | N Protein Standars SyCZW · Traditional | Behring Diagnostics, Inc. | 02/21/1996SE |
| K952594 | N Protein Standard SyCZW · Traditional | Behring Diagnostics, Inc. | 07/17/1995SE |
| K920007 | Il Test Complement 3CZW · Traditional | Instrumentation Laboratory CO | 06/16/1992SE |
| K911900 | Raichem Spia C3 ReagentCZW · Traditional | Reagents Applications, Inc. | 05/09/1991SE |
| K902382 | C3C and C4 Rid KitsCZW · Traditional | The Binding Site, Ltd. | 09/07/1990SE |
| K892127 | Ez Complement C3CZW · Traditional | Diamedix Corp. | 04/14/1989SE |
| K892125 | Ez Complement C2CZW · Traditional | Diamedix Corp. | 04/14/1989SE |
| K890675 | The Turbox Analyser System Complement C3 and C4CZW · Traditional | Unipath , Ltd. | 03/06/1989SE |
| K871939 | QM300 C3 Antibody PackCZW · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 06/12/1987SE |
| K871024 | Precimat(R) C3CZW · Traditional | Boehringer Mannheim Corp. | 05/15/1987SE |
| K871346 | Dako Ita(Tm) System, for Immunoturbidimetric AssayCZW · Traditional | Dako Corp. | 04/21/1987SE |
| K861362 | Immunomedics Serum Elisa Test SystemCZW · Traditional | Immunomedics, Inc. | 06/06/1986SE |
| K853466 | Gilford C3 Complement ReagentCZW · Traditional | Gilford | 09/16/1985SE |
| K851286 | Radial Immunodiffusion Plates C3 & C4CZW · Traditional | Cooper Biomedical, Inc. | 06/05/1985SE |
| K850588 | SPQ Test System for Complement C3CZW · Traditional | Applications Lab | 03/05/1985SE |
| K834604 | C3 Antiserum ControlCZW · Traditional | Technicon Instruments Corp. | 01/24/1984SE |
| K831905 | Rabbitt Antiserum to Human C3CCZW · Traditional | Dako Corp. | 07/18/1983SE |
| K830668 | Fiax Complement C3 Test KitCZW · Traditional | Intl. Diagnostic Technology | 04/05/1983SE |
| K812491 | Immunogl. Frct. of Rabbit ANTISER.-C3CZW · Traditional | Dako Corp. | 09/23/1981SE |
| K810501 | Scrippsystem C3 Rid KitCZW · Traditional | Scripps-Miles, Inc. | 04/08/1981SE |
| K801363 | Complement C3 Nephelometric AssayCZW · Traditional | J.T. Baker Chemical Co. | 06/30/1980SE |
| K800212 | Complement C3 Reagent SystemCZW · Traditional | Calbiochem-Behring Corp. | 02/19/1980SE |
| K791404 | Lancer L-Ina ANTI-C3CZW · Traditional | Sherwood Medical Co. | 10/17/1979SE |
| K781653 | Nephelrate Antiserums C3CCZW · Traditional | Antibodies, Inc. | 11/08/1978SE |
| K760148 | Serum, B1A Globulin C3C Goat Anti-HumanCZW · Traditional | Oxford Laboratories, Inc. | 07/20/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1987-2019 Class II | C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | Abbott Laboratories, Inc | 05/16/2018Terminated |