Data / Medical devices / C-Reactive Protein, Antigen, Antiserum, And Control / United States
FDA-registered makers of C-Reactive Protein, Antigen, Antiserum, And Control in the United States: 18 establishments
18 establishments in the United States are registered with the FDA to make C-Reactive Protein, Antigen, Antiserum, And Control (product code DCK). 15 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.
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- Device
- C-Reactive Protein, Antigen, Antiserum, And Control
- Product code
- DCK
- Country
- United States
Makers of C-Reactive Protein, Antigen, Antiserum, And Control in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Kamiya Biomedical Company LLC | Tukwila, WA, United States | Manufacturer, Repackager or relabeler | 5 | April 18, 2025 | 0 | 2 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Manufacturer, Specification developer | 3 | April 5, 2001 | 0 | 1 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer, Repackager or relabeler | 3 | July 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 3 | July 14, 2017 | 0 | 6 | 0 | api.fda.gov |
| Cliniqa Corporation | San Marcos, CA, United States | Manufacturer | 2 | July 29, 2002 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 2 | July 20, 2001 | 0 | 0 | 0 | api.fda.gov |
| Hemagen Diagnostics, Inc. | Baltimore, MD, United States | Manufacturer | 2 | March 12, 1996 | 0 | 0 | 0 | api.fda.gov |
| Horiba Instruments Incorporated | Canton, MI, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 2 | February 4, 2003 | 0 | 1 | 0 | api.fda.gov |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer, Repackager or relabeler | 2 | July 20, 2001 | 0 | 0 | 0 | api.fda.gov |
| Chembio Diagnostic Systems, Inc. | Medford, NY, United States | Complaint file establishment, Manufacturer | 1 | November 4, 2022 | 0 | 0 | 0 | api.fda.gov |
| Diazyme Laboratories, Inc. | Poway, CA, United States | Manufacturer | 1 | April 27, 2011 | 0 | 0 | 0 | api.fda.gov |
| Kent Laboratories, Inc. | Bellingham, WA, United States | Manufacturer | 1 | July 19, 1983 | 0 | 0 | 0 | api.fda.gov |
| KSL Biomedical, Inc. | Buffalo, NY, United States | Manufacturer | 1 | December 1, 1992 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 1 | September 24, 2015 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | August 4, 2000 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medica Corp. | Bedford, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.