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Data / Medical devices / Antigens, All Groups, Streptococcus Spp. / United States

FDA-registered makers of Antigens, All Groups, Streptococcus Spp. in the United States: 21 establishments

21 establishments in the United States are registered with the FDA to make Antigens, All Groups, Streptococcus Spp. (product code GTY). 15 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device
Antigens, All Groups, Streptococcus Spp.
Product code
GTY
Country
United States

Makers of Antigens, All Groups, Streptococcus Spp. in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Princeton Biomeditech Corp.Monmouth Jct, NJ, United StatesManufacturer4October 6, 2008000api.fda.gov
Princeton BioMeditech Corp.Plainsboro, NJ, United StatesManufacturer4October 6, 2008000api.fda.gov
Princeton BioMeditech Corp.Skillman, NJ, United StatesManufacturer4October 6, 2008000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler3January 31, 2014000api.fda.gov
Ortho-Clinical Diagnostics, Inc.San Diego, CA, United StatesSpecification developer3December 16, 2014000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Carlsbad, CA, United StatesManufacturer3December 16, 2014000api.fda.gov
Quidel Corp.San Diego, CA, United StatesComplaint file establishment, Manufacturer3December 16, 2014020api.fda.gov
Acon Laboratories, Inc.San Diego, CA, United StatesManufacturer, Specification developer1November 26, 2025000api.fda.gov
Alere San Diego, Inc.San Diego, CA, United StatesSpecification developer1May 7, 2001020api.fda.gov
Beckman Coulter, Inc.Miami, FL, United StatesSpecification developer1November 25, 1998000api.fda.gov
Becton, Dickinson & Co.San Diego, CA, United StatesSpecification developer1February 6, 2013000api.fda.gov
Becton, Dickinson & Co.Sparks, MD, United StatesComplaint file establishment, Manufacturer1February 6, 2013000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer1March 16, 2022000api.fda.gov
SA Scientific, LtdSan Antonio, TX, United StatesManufacturer, Repackager or relabeler1October 17, 2002000api.fda.gov
Sekisui Diagnostics, LLCSan Diego, CA, United StatesContract manufacturer, Manufacturer, Manufacturer for export1January 18, 2000000api.fda.gov
Aceso Laboratories Inc.Chino, CA, United StatesManufacturer0000api.fda.gov
Alfa Scientific Designs, Inc.Poway, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Keva Inc.Blaine, WA, United StatesManufacturer for export0000api.fda.gov
Lumiquick Diagnostics, Inc.Santa Clara, CA, United StatesManufacturer for export0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Wondfo USA Co., Ltd.San Diego, 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.