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Data / Medical devices / Test, Luteinizing Hormone (Lh), Over The Counter / United States

FDA-registered makers of Test, Luteinizing Hormone (Lh), Over The Counter in the United States: 21 establishments

21 establishments in the United States are registered with the FDA to make Test, Luteinizing Hormone (Lh), Over The Counter (product code NGE). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.

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Get makers of this device in the United StatesWatch these makers
Device
Test, Luteinizing Hormone (Lh), Over The Counter
Product code
NGE
Country
United States

Makers of Test, Luteinizing Hormone (Lh), Over The Counter in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Aceso Laboratories Inc.Chino, CA, United StatesManufacturer0000api.fda.gov
Acon Laboratories, Inc.San Diego, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Boston Easy Biotech IncBelmont, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Cordica Medical, Inc.Morristown, TN, United StatesContract manufacturer0000api.fda.gov
CorDx, Inc.Alpharetta, GA, United StatesManufacturer0000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer0000api.fda.gov
EazebioLivermore, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Genabio Diagnostics IncBedford, MA, United StatesSpecification developer0000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
HuedxPhiladelphia, PA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Ivd Research, LLC.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Keva Inc.Blaine, WA, United StatesManufacturer, Manufacturer for export0000api.fda.gov
Lady Technologies, Inc.San Francisco, CA, United StatesSpecification developer0000api.fda.gov
Med International IncOntario, CA, United StatesSpecification developer0000api.fda.gov
MFB Fertility, Inc.Boulder, CO, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Oova, Inc.New York, NY, United StatesSpecification developer0000api.fda.gov
Quanovate Tech Inc.San Ramon, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Syntron Bioresearch, Inc.Carlsbad, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
True Diagnostics, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Victorch Meditek, Inc.San Diego, CA, United StatesManufacturer for export0000api.fda.gov
W.H.P.M., Inc.Irwindale, CA, United StatesContract manufacturer0000api.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.