Data / Medical devices / Reagent, Occult Blood / United States
FDA-registered makers of Reagent, Occult Blood in the United States: 30 establishments
30 establishments in the United States are registered with the FDA to make Reagent, Occult Blood (product code KHE). 20 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
- Reagent, Occult Blood
- Product code
- KHE
- Country
- United States
Makers of Reagent, Occult Blood in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Immunostics, Inc. | Eatontown, NJ, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 5 | June 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer, Repackager or relabeler | 4 | June 21, 2007 | 0 | 1 | 0 | api.fda.gov |
| Alfa Scientific Designs, Inc. | Poway, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 3 | February 15, 2018 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 3 | February 15, 2018 | 0 | 0 | 0 | api.fda.gov |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 3 | January 28, 2011 | 0 | 0 | 0 | api.fda.gov |
| Propper MFG. Co., Inc. | Long Island City, NY, United States | Manufacturer | 3 | October 5, 1992 | 0 | 0 | 0 | api.fda.gov |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer, Repackager or relabeler | 3 | January 28, 2011 | 0 | 0 | 0 | api.fda.gov |
| Aerscher Diagnostics | Chestertown, MD, United States | Manufacturer | 2 | October 20, 1997 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Miami, FL, United States | Specification developer | 2 | June 25, 2008 | 0 | 0 | 0 | api.fda.gov |
| Biomerica | Irvine, CA, United States | Manufacturer | 1 | April 7, 1986 | 0 | 0 | 0 | api.fda.gov |
| Cenogenics Corp. | Morganville, NJ, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | December 21, 1976 | 0 | 0 | 0 | api.fda.gov |
| Enterix Inc. | Edison, NJ, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | October 5, 2017 | 0 | 3 | 0 | api.fda.gov |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 1 | October 3, 2005 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | San Diego, CA, United States | Specification developer | 1 | June 17, 2002 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Carlsbad, CA, United States | Manufacturer | 1 | June 17, 2002 | 0 | 0 | 0 | api.fda.gov |
| Princeton Biomeditech Corp. | Monmouth Jct, NJ, United States | Manufacturer | 1 | July 1, 2010 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Plainsboro, NJ, United States | Manufacturer | 1 | July 1, 2010 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Skillman, NJ, United States | Manufacturer | 1 | July 1, 2010 | 0 | 0 | 0 | api.fda.gov |
| Quidel Corp. | San Diego, CA, United States | Complaint file establishment, Manufacturer | 1 | June 17, 2002 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Specification developer | 1 | March 7, 1983 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Hialeah, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Easy Biotech Inc | Belmont, MA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keva Inc. | Blaine, WA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lumiquick Diagnostics, Inc. | Santa Clara, 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 | |
| The Belport Company, Inc DBA Gingi-Pak | Camarillo, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Venture Solutions | Arden Hills, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| W.H.P.M., Inc. | Irwindale, CA, United States | Contract 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.