Data / Medical devices / Drug Mixture Control Materials / United States
FDA-registered makers of Drug Mixture Control Materials in the United States: 22 establishments
22 establishments in the United States are registered with the FDA to make Drug Mixture Control Materials (product code DIF). 14 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- Drug Mixture Control Materials
- Product code
- DIF
- Country
- United States
Makers of Drug Mixture Control Materials in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Manufacturer | 16 | May 18, 2012 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Manufacturer | 16 | May 18, 2012 | 0 | 0 | 0 | api.fda.gov |
| Utak Laboratories, Inc. | Valencia, CA, United States | Manufacturer | 14 | November 2, 1994 | 0 | 0 | 0 | api.fda.gov |
| Biochemical Diagnostics, Inc. | Edgewood, NY, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 4 | February 23, 2016 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 3 | October 28, 1998 | 0 | 0 | 0 | api.fda.gov |
| Microgenics Corporation | Fremont, CA, United States | Contract manufacturer, Manufacturer | 2 | April 30, 2008 | 0 | 0 | 0 | api.fda.gov |
| Elsohly Labs, Inc. | Oxford, MS, United States | Manufacturer | 1 | June 19, 1995 | 0 | 0 | 0 | api.fda.gov |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 1 | July 3, 2012 | 0 | 0 | 0 | api.fda.gov |
| Medtox Diagnostics, Inc. | Burlington, NC, United States | Specification developer | 1 | February 23, 2016 | 0 | 0 | 0 | api.fda.gov |
| Medtox Diagnostics, Inc. | Burlington, NC, United States | Specification developer | 1 | February 23, 2016 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer, Repackager or relabeler | 1 | August 22, 1990 | 0 | 1 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | August 22, 1990 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 1 | August 21, 2006 | 0 | 0 | 0 | api.fda.gov |
| The Quality Assurance Service Corp. | Martinez, GA, United States | Manufacturer | 1 | December 17, 1981 | 0 | 0 | 0 | api.fda.gov |
| Alere San Diego, Inc. | Pomona, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bionostics, Inc. | Devens, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infrared Laboratory Systems dba SYNERMED | Westfield, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lin-Zhi International, Inc. | Santa Clara, CA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Quidel Cardiovascular Inc. | San Diego, CA, United States | Manufacturer, Manufacturer for export | 0 | 0 | 1 | 0 | api.fda.gov | |
| Stanbio Laboratory | Boerne, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 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.