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Data / Medical devices / Helicobacter Pylori / United States

FDA-registered makers of Helicobacter Pylori in the United States: 31 establishments

31 establishments in the United States are registered with the FDA to make Helicobacter Pylori (product code LYR). 22 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 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
Helicobacter Pylori
Product code
LYR
Country
United States

Makers of Helicobacter Pylori in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Meridian Bioscience, Inc.Cincinnati, OH, United StatesManufacturer7July 3, 2023010api.fda.gov
BiomericaIrvine, CA, United StatesManufacturer, Manufacturer for export2December 15, 2023000api.fda.gov
Diasorin Inc.Stillwater, MN, United StatesManufacturer2August 31, 2018000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer, Repackager or relabeler2June 10, 2003000api.fda.gov
Inova Diagnostics, Inc.San Diego, CA, United StatesManufacturer2March 27, 2003000api.fda.gov
Techlab, Inc.Radford, VA, United StatesManufacturer2August 21, 2018000api.fda.gov
Techlab, Inc.Blacksburg, VA, United StatesManufacturer2August 21, 2018000api.fda.gov
Zeus Scientific LLCBranchburg, NJ, United StatesManufacturer2August 12, 1999000api.fda.gov
Alfa Scientific Designs, Inc.Poway, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler1June 10, 2003000api.fda.gov
ARJ MEDICAL, LLC. / Gulf Coast Scientific, LLC.Tampa, FL, United StatesManufacturer1May 1, 2006000api.fda.gov
Avanos Medical, Inc.Alpharetta, GA, United StatesSpecification developer1October 6, 1988000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler1June 10, 2003000api.fda.gov
Kenlor Industries, Inc.Santa Ana, CA, United StatesContract manufacturer, Manufacturer1March 3, 1997000api.fda.gov
Micro Detect, Inc.Tustin, CA, United StatesManufacturer1March 10, 1998000api.fda.gov
Princeton Biomeditech Corp.Monmouth Jct, NJ, United StatesManufacturer1September 22, 1998000api.fda.gov
Princeton BioMeditech Corp.Plainsboro, NJ, United StatesManufacturer1September 22, 1998000api.fda.gov
Princeton BioMeditech Corp.Skillman, NJ, United StatesManufacturer1September 22, 1998000api.fda.gov
Remel, Inc.Lenexa, KS, United StatesManufacturer1May 4, 1989000api.fda.gov
Serim Research Corp.Elkhart, IN, United StatesManufacturer1December 18, 1995000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer1June 1, 2000000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer1June 10, 2003000api.fda.gov
Trinity Biotech USAJamestown, NY, United StatesManufacturer, Manufacturer for export1November 26, 2003000api.fda.gov
Boston Easy Biotech IncBelmont, MA, United StatesManufacturer for export0000api.fda.gov
CTK Biotech, Inc.Poway, CA, United StatesManufacturer for export0000api.fda.gov
DIAMOND DIAGNOSTICS IncHolliston, MA, United StatesContract manufacturer0000api.fda.gov
Epitope Diagnostics, Inc.San Diego, CA, United StatesManufacturer for export0000api.fda.gov
Immunocentrix CorporationCanoga Park, CA, United StatesManufacturer for export0000api.fda.gov
Keva Inc.Blaine, WA, United StatesManufacturer for export0000api.fda.gov
Lumiquick Diagnostics, Inc.Santa Clara, CA, United StatesContract manufacturer0000api.fda.gov
Monobind, Inc.Lake Forest, CA, United StatesManufacturer for export0000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, 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.