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Data / Medical devices / Kit, Test, Pregnancy, Hcg, Over The Counter / United States

FDA-registered makers of Kit, Test, Pregnancy, Hcg, Over The Counter in the United States: 28 establishments

28 establishments in the United States are registered with the FDA to make Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX). 21 have a 510(k) clearance or PMA approval on file and 1 has a recall event. 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.

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Device
Kit, Test, Pregnancy, Hcg, Over The Counter
Product code
LCX
Country
United States

Makers of Kit, Test, Pregnancy, Hcg, Over The Counter in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Aceso Laboratories Inc.Chino, CA, United StatesManufacturer4July 15, 2025000api.fda.gov
Church & Dwight Co., Inc.Princeton, NJ, United StatesComplaint file establishment, Specification developer4September 10, 2013010api.fda.gov
Assure Tech LLCWilmington, DE, United StatesRepackager or relabeler, Specification developer3February 13, 2025000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer3June 30, 2022000api.fda.gov
Syntron Bioresearch, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer3May 15, 2019000api.fda.gov
ABOUND Diagnostics, IncSan Diego, CA, United StatesSpecification developer2August 13, 2024000api.fda.gov
Acon Laboratories, Inc.San Diego, CA, United StatesManufacturer, Specification developer2May 31, 2024000api.fda.gov
Boston Easy Biotech IncBelmont, MA, United StatesComplaint file establishment, Specification developer2November 30, 2022000api.fda.gov
Princeton Biomeditech Corp.Monmouth Jct, NJ, United StatesManufacturer2February 10, 1995000api.fda.gov
Princeton BioMeditech Corp.Plainsboro, NJ, United StatesManufacturer2February 10, 1995000api.fda.gov
Princeton BioMeditech Corp.Skillman, NJ, United StatesManufacturer2February 10, 1995000api.fda.gov
Alfa Scientific Designs, Inc.Poway, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler1February 16, 1999000api.fda.gov
Chemtron Biotech, Inc.San Diego, CA, United StatesManufacturer1July 26, 2013000api.fda.gov
CorDx, Inc.Alpharetta, GA, United StatesManufacturer1October 2, 2015000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer, Repackager or relabeler1February 16, 1999000api.fda.gov
Med International IncOntario, CA, United StatesSpecification developer1April 10, 2013000api.fda.gov
NOVODX CorporationJupiter, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1February 5, 2024000api.fda.gov
Ouachita Contract Manufacturing, LLCMonroe, LA, United StatesRepackager or relabeler, Specification developer1November 12, 2013000api.fda.gov
Phamatech Inc.San Diego, CA, United StatesContract manufacturer, Manufacturer1November 8, 1999000api.fda.gov
SA Scientific, LtdSan Antonio, TX, United StatesManufacturer1May 4, 1999000api.fda.gov
Scantibodies Laboratory Inc.San Diego, CA, United StatesManufacturer1February 25, 2003000api.fda.gov
BiomericaIrvine, CA, United StatesManufacturer for export0000api.fda.gov
Cordica Medical, Inc.Morristown, TN, United StatesContract manufacturer0000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Keva Inc.Blaine, WA, United StatesManufacturer for export0000api.fda.gov
Nowdiagnostics, Inc.Springdale, AR, United StatesManufacturer for export0000api.fda.gov
True Diagnostics, Inc.Carlsbad, CA, United StatesSpecification developer0000api.fda.gov
W.H.P.M., Inc.Irwindale, CA, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 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.