Data / Medical devices / Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control / United States
FDA-registered makers of Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (product code DAP). 4 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- Product code
- DAP
- Country
- United States
Makers of Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Instrumentation Laboratory Co. | Bedford, MA, United States | Specification developer | 6 | November 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 5 | May 16, 2011 | 0 | 4 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Specification developer | 4 | May 16, 2011 | 0 | 1 | 0 | api.fda.gov |
| Kamiya Biomedical Company LLC | Tukwila, WA, United States | Manufacturer | 1 | June 27, 2003 | 0 | 0 | 0 | api.fda.gov |
| DIAMOND DIAGNOSTICS Inc | Holliston, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diazyme Laboratories, Inc. | Poway, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HiArc | Merrimack, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nano-Ditech Corporation | Cranbury, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Princeton Biomeditech Corp. | Monmouth Jct, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quidel Cardiovascular Inc. | San Diego, CA, United States | Manufacturer, Manufacturer for export | 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.