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Data / Medical devices / Enzyme Immunoassay, Gentamicin

Enzyme Immunoassay, Gentamicin (LCD): 14 FDA-registered makers in 4 countries

14 establishments in 4 countries are registered with the FDA to make Enzyme Immunoassay, Gentamicin (product code LCD, Class 2, 21 CFR 862.3450). 9 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 37 510(k) clearances under this code, the latest on July 9, 2025, and lists 9 recall events (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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
LCD
Device class
2
Regulation
862.3450
Medical specialty
Clinical Toxicology

Makers by country

CountryMakers
United States9
Germany2
United Kingdom2
Ireland1

Makers of Enzyme Immunoassay, Gentamicin

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Microgenics CorporationFremont, CA, United StatesContract manufacturer, Manufacturer3June 15, 2006000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesContract manufacturer, Manufacturer, Specification developer3April 20, 2001020api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer3September 18, 2001000api.fda.gov
ABBOTT GmbHWiesbaden Hesse, GermanyManufacturer2July 9, 2025010api.fda.gov
B.R.A.H.M.S GmbHHENNIGSDORF Brandenburg, GermanySpecification developer1June 15, 2006000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer, Repackager or relabeler1January 6, 2005000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1January 6, 2005010api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomContract manufacturer, Manufacturer1September 18, 2001000api.fda.gov
Siemens Healthcare Diagnostics Products LimitedLLANBERIS Wales, United KingdomManufacturer1August 20, 2001000api.fda.gov
Ark Diagnostics IncFremont, CA, United StatesManufacturer for export0000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesManufacturer, Specification developer0010api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Manufacturing Ltd.SWORDS Dublin(County), IrelandManufacturer0000api.fda.gov

Updated July 9, 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.