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Data / Medical devices / Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method / United States

FDA-registered makers of Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method in the United States: 11 establishments

11 establishments in the United States are registered with the FDA to make Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (product code DIC). 9 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.

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Device
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Product code
DIC
Country
United States

Makers of Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer4August 24, 2007000api.fda.gov
Chematics, Inc.North Webster, IN, United StatesContract manufacturer, Manufacturer2March 22, 2013000api.fda.gov
Horiba Instruments IncorporatedCanton, MI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler2October 3, 2003000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer2August 24, 2007010api.fda.gov
Alere San Diego, Inc.Pomona, CA, United StatesManufacturer1October 31, 2018000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler1August 6, 2010000api.fda.gov
Lin-Zhi International, Inc.Santa Clara, CA, United StatesManufacturer1October 3, 2003010api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer1November 15, 2011000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer1October 4, 2011000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov

Updated November 3, 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.