Data / Medical devices / Drug Specific Control Materials
Drug Specific Control Materials (LAS): 20 FDA-registered makers in 4 countries
20 establishments in 4 countries are registered with the FDA to make Drug Specific Control Materials (product code LAS, Class 1, 21 CFR 862.3280). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 83 510(k) clearances under this code, the latest on November 17, 2009, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- LAS
- Device class
- 1
- Regulation
- 862.3280
- Medical specialty
- Clinical Toxicology
Makers by country
| Country | Makers |
|---|---|
| United States | 14 |
| Germany | 3 |
| United Kingdom | 2 |
| Switzerland | 1 |
Makers of Drug Specific Control Materials
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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Specification developer | 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 | |
| Bedfont Scientific Ltd. | MAIDSTONE Kent, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chromsystems Instruments & Chemicals GMBH | Gräfelfing Bavaria, Germany | Manufacturer | 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 | |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | PENZBERG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 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 17, 2009. 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.