Data / Medical devices / Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (DIC): 18 FDA-registered makers in 5 countries
18 establishments in 5 countries are registered with the FDA to make Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (product code DIC, Class 2, 21 CFR 862.3040). 10 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 33 510(k) clearances under this code, the latest on September 15, 2025, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DIC
- Device class
- 2
- Regulation
- 862.3040
- Medical specialty
- Clinical Toxicology
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| China | 3 |
| Germany | 2 |
| Canada | 1 |
| Switzerland | 1 |
Makers of Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
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 | Manufacturer | 4 | August 24, 2007 | 0 | 0 | 0 | api.fda.gov |
| Chematics, Inc. | North Webster, IN, United States | Contract manufacturer, Manufacturer | 2 | March 22, 2013 | 0 | 0 | 0 | api.fda.gov |
| Horiba Instruments Incorporated | Canton, MI, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 2 | October 3, 2003 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | August 24, 2007 | 0 | 1 | 0 | api.fda.gov |
| Alere San Diego, Inc. | Pomona, CA, United States | Manufacturer | 1 | October 31, 2018 | 0 | 0 | 0 | api.fda.gov |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 1 | August 6, 2010 | 0 | 0 | 0 | api.fda.gov |
| Lin-Zhi International, Inc. | Santa Clara, CA, United States | Manufacturer | 1 | October 3, 2003 | 0 | 1 | 0 | api.fda.gov |
| Medica Corp. | Bedford, MA, United States | Manufacturer | 1 | November 15, 2011 | 0 | 0 | 0 | api.fda.gov |
| Sekisui Diagnostics P.E.I. Inc. | CHARLOTTETOWN Prince Edward Island, Canada | Contract manufacturer, Manufacturer | 1 | June 20, 2000 | 0 | 0 | 0 | api.fda.gov |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer | 1 | October 4, 2011 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Wondfo Biotech Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, 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 | |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 15, 2025. 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.