Data / Medical devices / Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (DAP): 24 FDA-registered makers in 10 countries
24 establishments in 10 countries are registered with the FDA to make Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (product code DAP, Class 2, 21 CFR 864.7320). 12 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 58 510(k) clearances under this code, the latest on August 11, 2026, and lists 12 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- DAP
- Device class
- 2
- Regulation
- 864.7320
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| France | 3 |
| Spain | 1 |
| Germany | 1 |
| Ireland | 1 |
| Canada | 1 |
| United Kingdom | 1 |
| Japan | 1 |
| Italy | 1 |
| Hungary | 1 |
Makers of Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 |
| Biokit S.A. | LLISSA D AMUNT Barcelona, Spain | Manufacturer, Specification developer | 5 | November 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Diagnostica Stago - Taverny | Taverny Val-d'Oise, France | Exporter to the US, Manufacturer | 5 | December 10, 2016 | 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 |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer | 4 | August 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| Tcoag Ireland Limited | BRAY Wicklow, Ireland | Manufacturer | 2 | November 15, 2001 | 0 | 0 | 0 | api.fda.gov |
| Biomedica Diagnostics Inc. | Windsor Nova Scotia, Canada | Manufacturer | 1 | February 13, 2008 | 0 | 0 | 0 | api.fda.gov |
| Biomerieux SA | MARCY L ETOILE Rhone, France | Manufacturer | 1 | July 31, 2012 | 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 |
| Remel Europe Ltd | Dartford, Kent, United Kingdom | Manufacturer, Specification developer | 1 | January 31, 1992 | 0 | 0 | 0 | api.fda.gov |
| Shima Laboratories Co., Ltd. | ITABASHI-KU Tokyo, Japan | Contract manufacturer, Manufacturer | 1 | June 27, 2003 | 0 | 0 | 0 | api.fda.gov |
| Biomerieux Italia-Industrial Div. | PONTE-A EMA, FLORENCE Firenze, Italy | Manufacturer | 0 | 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 | |
| Diagnostica Stago - Gennevilliers | Gennevilliers Hauts-de-Seine, France | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diamond Diagnostics Inc. | Budapest, Hungary | Contract 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 August 11, 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.