Data / Medical devices / Enzyme Immunoassay, Valproic Acid
Enzyme Immunoassay, Valproic Acid (LEG): 15 FDA-registered makers in 5 countries
15 establishments in 5 countries are registered with the FDA to make Enzyme Immunoassay, Valproic Acid (product code LEG, Class 2, 21 CFR 862.3645). 11 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 35 510(k) clearances under this code, the latest on August 6, 2009, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LEG
- Device class
- 2
- Regulation
- 862.3645
- Medical specialty
- Clinical Toxicology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Germany | 3 |
| United Kingdom | 2 |
| Japan | 1 |
| Switzerland | 1 |
Makers of Enzyme Immunoassay, Valproic Acid
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 |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Contract manufacturer, Manufacturer, Specification developer | 3 | July 2, 2001 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 3 | January 15, 2002 | 0 | 1 | 0 | api.fda.gov |
| Microgenics Corporation | Fremont, CA, United States | Contract manufacturer, Manufacturer | 2 | April 28, 2003 | 0 | 0 | 0 | api.fda.gov |
| B.R.A.H.M.S GmbH | HENNIGSDORF Brandenburg, Germany | Specification developer | 1 | April 28, 2003 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 1 | July 15, 2003 | 0 | 0 | 0 | api.fda.gov |
| Denka Co., Ltd. | GOSEN-SHI Niigata, Japan | Manufacturer | 1 | August 6, 2009 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer, Repackager or relabeler | 1 | December 1, 2004 | 0 | 1 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | December 1, 2004 | 0 | 2 | 0 | api.fda.gov |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Contract manufacturer, Manufacturer | 1 | January 15, 2002 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 1 | August 8, 2006 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 1 | March 3, 2000 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract 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 | |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 6, 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.