Complement C4, Antigen, Antiserum, Control
FDA product code DBI · Class II (moderate risk) · 21 CFR 866.5240 · Immunology
34510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Kallestad Laboratories, Inc. 2
- The Binding Site, Ltd. 2
- Crestat Diagnostics, Inc. 2
- Instrumentation Laboratory CO 2
- Boehringer Mannheim Corp. 2
- Technicon Instruments Corp. 2
- Dako Corp. 2
- G.D. Searle and Co. 2
- Intl. Diagnostic Technology 1
- Scripps-Miles, Inc. 1
- Applications Lab 1
- Gilford 1
- Protos Laboratories 1
- Kallestad Diag, A Div. of Erbamont, Inc. 1
- Atlantic Antibodies 1
- Diamedix Corp. 1
- Reagents Applications, Inc. 1
- J.T. Baker Chemical Co. 1
- Olympus America, Inc. 1
- Gelman Instrument Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100455 | Spaplus AnalyzerDBI · Traditional | The Binding Site | 09/03/2010SE |
| K012359 | Tina-Quant Complement C4 Test SystemDBI · Traditional | Roche Diagnostics Corp. | 11/29/2001SE |
| K010325 | Wako Autokit C4DBI · Traditional | Wako Chemicals USA, Inc. | 06/25/2001SE |
| K000468 | Randox Complement C4DBI · Traditional | Randox Laboratories, Ltd. | 03/27/2000SE |
| K994293 | Dimension C4 Flex Reagent CartridgeDBI · Traditional | Dade Behring, Inc. | 03/01/2000SE |
| K981785 | C4 Minineph AntiserumDBI · Traditional | The Binding Site, Ltd. | 12/20/1999SE |
| K993481 | K-Assay C4DBI · Traditional | Kamiya Biomedical Co. | 11/29/1999SE |
| K983356 | C4DBI · Traditional | Abbott Laboratories | 11/04/1998SE |
| K964300 | N-Assay Tia Multi V-NlDBI · Traditional | Crestat Diagnostics, Inc. | 07/14/1997SE |
| K964297 | N-Assay Tia C4 Test KitDBI · Traditional | Crestat Diagnostics, Inc. | 07/14/1997SE |
| K962582 | Olympus C4 Immunoturbidimetric ReagentDBI · Traditional | Olympus America, Inc. | 10/18/1996SE |
| K962198 | Quantex C4DBI · Traditional | Instrumentation Laboratory CO | 09/26/1996SE |
| K920010 | Il Test Complement 4DBI · Traditional | Instrumentation Laboratory CO | 03/13/1992SE |
| K911899 | Raichem Spia C4 ReagentDBI · Traditional | Reagents Applications, Inc. | 05/09/1991SE |
| K892129 | Ez Complement C4DBI · Traditional | Diamedix Corp. | 04/14/1989SE |
| K890564 | Spq(Tm) Antibody Reagent Set II for C4DBI · Traditional | Atlantic Antibodies | 02/17/1989SE |
| K882621 | Complement C4 for the Technicon DPA-1(TM) SystemDBI · Traditional | Technicon Instruments Corp. | 07/08/1988SE |
| K872599 | QM300 C4 Antibody PackDBI · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 07/23/1987SE |
| K871023 | Precimat(R) C4DBI · Traditional | Boehringer Mannheim Corp. | 05/14/1987SE |
| K870931 | Tina-Quant(R) (a) C4DBI · Traditional | Boehringer Mannheim Corp. | 03/24/1987SE |
| K855012 | Quantimetric Plus C4 Reagent KitDBI · Traditional | Kallestad Laboratories, Inc. | 02/26/1986SE |
| K853468 | Gilford C4 Complement ReagentDBI · Traditional | Gilford | 09/16/1985SE |
| K850585 | SPQ Test System for Complement C4DBI · Traditional | Applications Lab | 03/01/1985SE |
| K834605 | C4 Antigen Antibody ControlDBI · Traditional | Technicon Instruments Corp. | 01/24/1984SE |
| K831906 | Rabbit Antiserum to Human C4DBI · Traditional | Dako Corp. | 07/19/1983SE |
| K830669 | Fiax Complement C4 Test KitDBI · Traditional | Intl. Diagnostic Technology | 04/08/1983SE |
| K812490 | Immunogl. Frct. of Rabbit ANTISER.-C4DBI · Traditional | Dako Corp. | 09/23/1981SE |
| K810502 | Scrippsystem C4 Rid KitDBI · Traditional | Scripps-Miles, Inc. | 04/08/1981SE |
| K802196 | Goat Anti-Human Complement C4DBI · Traditional | Protos Laboratories | 10/31/1980SE |
| K801361 | Complement C4 Nephelometric AssayDBI · Traditional | J.T. Baker Chemical Co. | 06/30/1980SE |
| K772073 | Radial Immunodiffusion Kit-Comp. 3DBI · Traditional | Gelman Instrument Co. | 02/03/1978SE |
| K772247 | Complement C4 Nephelometric AssayDBI · Traditional | Kallestad Laboratories, Inc. | 12/22/1977SE |
| K772004 | Human C4 Complement Control SerumDBI · Traditional | G.D. Searle and Co. | 11/03/1977SE |
| K772002 | Plates for Human C4 ComplementDBI · Traditional | G.D. Searle and Co. | 11/02/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0103-2021 Class III | Tina-quant Complement C4 ver.2, Catalog 05991994190Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the… | Roche Diagnostics Operations, Inc. | 08/27/2020Terminated |
| Z-1992-2019 Class II | C4 is an in vitro diagnostic assay for the quantitative determination of C4 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 |