Data / Medical devices / Drug Specific Control Materials / United States
FDA-registered makers of Drug Specific Control Materials in the United States: 14 establishments
14 establishments in the United States are registered with the FDA to make Drug Specific Control Materials (product code LAS). 6 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Drug Specific Control Materials
- Product code
- LAS
- Country
- United States
Makers of Drug Specific Control Materials in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Utak Laboratories, Inc. | Valencia, CA, United States | Manufacturer | 8 | April 12, 1991 | 0 | 0 | 0 | api.fda.gov |
| More Diagnostics Inc. | Los Osos, CA, United States | Manufacturer | 2 | January 30, 2008 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Manufacturer for export | 2 | November 29, 1988 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 1 | April 17, 1997 | 0 | 0 | 0 | api.fda.gov |
| Microgenics Corporation | Fremont, CA, United States | Contract manufacturer, Manufacturer | 1 | May 27, 2004 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | April 17, 1992 | 0 | 0 | 0 | api.fda.gov |
| Ark Diagnostics Inc | Fremont, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alere San Diego, Inc. | Pomona, CA, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| DTPM Inc. | Fort Payne, AL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| INSTRUMENTATION LABORATORY CO. - Devens | Devens, MA, United States | Manufacturer for export, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lin-Zhi International, Inc. | Santa Clara, CA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Medica Corp. | Bedford, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saladax Biomedical, Inc. | Bethlehem, PA, 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.