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Data / Medical devices / Visual, Pregnancy Hcg, Prescription Use / United States

FDA-registered makers of Visual, Pregnancy Hcg, Prescription Use in the United States: 38 establishments

38 establishments in the United States are registered with the FDA to make Visual, Pregnancy Hcg, Prescription Use (product code JHI). 31 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.

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Device
Visual, Pregnancy Hcg, Prescription Use
Product code
JHI
Country
United States

Makers of Visual, Pregnancy Hcg, Prescription Use in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Teco DiagnosticsAnaheim, CA, United StatesManufacturer, Repackager or relabeler, Specification developer6July 22, 1999000api.fda.gov
Alfa Scientific Designs, Inc.Poway, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler5December 23, 2003000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer, Manufacturer for export5January 31, 2022000api.fda.gov
Alere San Diego, Inc.San Diego, CA, United StatesSpecification developer4October 23, 2006030api.fda.gov
Ortho-Clinical Diagnostics, Inc.San Diego, CA, United StatesSpecification developer3May 17, 2002000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Carlsbad, CA, United StatesManufacturer3May 17, 2002000api.fda.gov
Princeton Biomeditech Corp.Monmouth Jct, NJ, United StatesManufacturer3January 23, 2006010api.fda.gov
Princeton BioMeditech Corp.Plainsboro, NJ, United StatesManufacturer3January 23, 2006000api.fda.gov
Princeton BioMeditech Corp.Skillman, NJ, United StatesManufacturer3January 23, 2006000api.fda.gov
Quidel Corp.San Diego, CA, United StatesComplaint file establishment, Manufacturer3May 17, 2002010api.fda.gov
Sekisui Diagnostics, LLCSan Diego, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer3April 12, 2005000api.fda.gov
Beckman Coulter, Inc.Miami, FL, United StatesSpecification developer2May 23, 2002000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler2April 16, 1998000api.fda.gov
Lumiquick Diagnostics, Inc.Santa Clara, CA, United StatesManufacturer, Repackager or relabeler2July 22, 1999000api.fda.gov
SA Scientific, LtdSan Antonio, TX, United StatesContract manufacturer, Manufacturer2May 10, 1999000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer2December 23, 2003010api.fda.gov
ABOUND Diagnostics, IncSan Diego, CA, United StatesSpecification developer1January 31, 2022000api.fda.gov
Aceso Laboratories Inc.Chino, CA, United StatesManufacturer1January 31, 2022000api.fda.gov
Ameritekusa, Inc.Everett, WA, United StatesManufacturer1December 17, 1997000api.fda.gov
Assure Tech LLCWilmington, DE, United StatesRepackager or relabeler, Specification developer1February 24, 2016000api.fda.gov
BiomericaIrvine, CA, United StatesManufacturer, Repackager or relabeler1February 21, 2001000api.fda.gov
Cenogenics Corp.Morganville, NJ, United StatesManufacturer1August 26, 1999000api.fda.gov
LSL HealthcareNiles, IL, United StatesManufacturer, Repackager or relabeler1July 17, 2012000api.fda.gov
Nowdiagnostics, Inc.Springdale, AR, United StatesManufacturer1March 18, 2004000api.fda.gov
Phamatech Inc.San Diego, CA, United StatesManufacturer, Repackager or relabeler1January 26, 1998000api.fda.gov
Qualigen, Inc.Carlsbad, CA, United StatesManufacturer1December 6, 2007000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer for export, Repackager or relabeler, Specification developer1June 21, 2002000api.fda.gov
Syntron Bioresearch, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer1December 22, 2017000api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesSpecification developer1December 23, 2003020api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer1March 19, 1993000api.fda.gov
True Diagnostics, Inc.Carlsbad, CA, United StatesSpecification developer1December 22, 2017000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesManufacturer0050api.fda.gov
CTK Biotech, Inc.Poway, CA, United StatesManufacturer for export0000api.fda.gov
DIAMOND DIAGNOSTICS IncHolliston, MA, United StatesContract manufacturer0000api.fda.gov
Immunocentrix CorporationCanoga Park, CA, United StatesManufacturer for export0000api.fda.gov
Maxim Biomedical Inc.Rockville, MD, United StatesContract manufacturer0000api.fda.gov
Nano-Ditech CorporationCranbury, NJ, United StatesManufacturer for export0000api.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.