DBI · Complement C4, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5240 · Class 2
Overview
| Product Code | DBI |
|---|---|
| Device Name | Complement C4, 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 34)
Showing 20 most recent of 34 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K100455 | SPAPLUS ANALYZER | The Binding Site | Sep 3, 2010 | SESE |
| K012359 | TINA-QUANT COMPLEMENT C4 TEST SYSTEM | Roche Diagnostics Corp. | Nov 29, 2001 | SESE |
| K010325 | WAKO AUTOKIT C4 | Wako Chemicals USA, Inc. | Jun 25, 2001 | SESE |
| K000468 | RANDOX COMPLEMENT C4 | Randox Laboratories, Ltd. | Mar 27, 2000 | SESE |
| K994293 | DIMENSION C4 FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Mar 1, 2000 | SESE |
| K981785 | C4 MININEPH ANTISERUM | The Binding Site, Ltd. | Dec 20, 1999 | SESE |
| K993481 | K-ASSAY C4 | Kamiya Biomedical Co. | Nov 29, 1999 | SESE |
| K983356 | C4 | Abbott Laboratories | Nov 4, 1998 | SESE |
| K964300 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | Jul 14, 1997 | SESE |
| K964297 | N-ASSAY TIA C4 TEST KIT | Crestat Diagnostics, Inc. | Jul 14, 1997 | SESE |
| K962582 | OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | Oct 18, 1996 | SESE |
| K962198 | QUANTEX C4 | Instrumentation Laboratory CO | Sep 26, 1996 | SESE |
| K920010 | IL TEST COMPLEMENT 4 | Instrumentation Laboratory CO | Mar 13, 1992 | SESE |
| K911899 | RAICHEM SPIA C4 REAGENT | Reagents Applications, Inc. | May 9, 1991 | SESE |
| K892129 | EZ COMPLEMENT C4 | Diamedix Corp. | Apr 14, 1989 | SESE |
| K890564 | SPQ(TM) ANTIBODY REAGENT SET II FOR C4 | Atlantic Antibodies | Feb 17, 1989 | SESE |
| K882621 | COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | Jul 8, 1988 | SESE |
| K872599 | QM300 C4 ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | Jul 23, 1987 | SESE |
| K871023 | PRECIMAT(R) C4 | Boehringer Mannheim Corp. | May 14, 1987 | SESE |
| K870931 | TINA-QUANT(R) (A) C4 | Boehringer Mannheim Corp. | Mar 24, 1987 | SESE |
Top Applicants
- Technicon Instruments Corp. — 2 clearances
- Kallestad Laboratories, Inc. — 2 clearances
- Instrumentation Laboratory CO — 2 clearances
- G.D. Searle and Co. — 2 clearances
- Dako Corp. — 2 clearances
