Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
FDA product code DBA · Class II (moderate risk) · 21 CFR 866.5250 · Immunology
13510(k) clearances
0PMA approvals
1recalls
Manufacturers
- The Binding Site Group , Ltd. 2
- Hyland Therapeutic Div., Travenol Laboratories 1
- Icl Scientific 1
- Ortho Diagnostic Systems, Inc. 1
- Cytotech, Inc. 1
- The Binding Site, Ltd. 1
- Kent Laboratories, Inc. 1
- Behring Diagnostics, Inc. 1
- Crestat Diagnostics, Inc. 1
- Baxter Healthcare Corp 1
- Kamiya Biomedical Co. 1
- Dade Behring, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K141100 | Optilite C1 Inactivator KitDBA · Traditional | The Binding Site Group , Ltd. | 07/18/2014SE |
| K122304 | Human C1 Inactivator Kit for Use on SpaplusDBA · Traditional | The Binding Site Group , Ltd. | 04/15/2013SE |
| K072965 | Dimension Vista C1 in; Flex Reagent Cartridge, Cal, ConDBA · Traditional | Dade Behring, Inc. | 12/21/2007SE |
| K011780 | K-Assay C1-INADBA · Traditional | Kamiya Biomedical Co. | 07/25/2001SE |
| K003747 | C1-INHIBITOR Microtiter Assay DeviceDBA · Traditional | Baxter Healthcare Corp | 03/19/2001SE |
| K965024 | N-Assay Tia C1-INACTIVATOR Test KitDBA · Traditional | Crestat Diagnostics, Inc. | 07/14/1997SE |
| K960257 | N Antiserum to C1 InhibitorDBA · Traditional | Behring Diagnostics, Inc. | 08/01/1996SE |
| K951967 | Human C1 Inactivator or C-1 Esterase Inhibitor Radial Immunodiffusion KitDBA · Traditional | Kent Laboratories, Inc. | 05/30/1995SE |
| K915431 | Complement C1 Inactivator KitDBA · Traditional | The Binding Site, Ltd. | 01/17/1992SE |
| K872426 | Cytotech C1-INHIBITOR Enzyme ImmunoassayDBA · Traditional | Cytotech, Inc. | 07/23/1987SE |
| K821898 | Ortho Classical Pathway Compl. TestDBA · Traditional | Ortho Diagnostic Systems, Inc. | 07/16/1982SE |
| K781017 | Anti-Human C1 Inhibitor Serum (Goat)DBA · Traditional | Icl Scientific | 08/14/1978SE |
| K780335 | Las-R Human C1 Esterase Inhibitor TestDBA · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 03/22/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1308-2023 Class II | MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor…Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail… | Quidel Corporation | 02/01/2023Open, Classified |