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Data / Medical devices / Single (Specified) Analyte Controls (Assayed And Unassayed) / United States

FDA-registered makers of Single (Specified) Analyte Controls (Assayed And Unassayed) in the United States: 94 establishments

94 establishments in the United States are registered with the FDA to make Single (Specified) Analyte Controls (Assayed And Unassayed) (product code JJX). 34 have a 510(k) clearance or PMA approval on file and 8 have a recall event. FDA data exported November 2, 2026.

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Device
Single (Specified) Analyte Controls (Assayed And Unassayed)
Product code
JJX
Country
United States

Makers of Single (Specified) Analyte Controls (Assayed And Unassayed) in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer17July 17, 2015000api.fda.gov
Cliniqa CorporationSan Marcos, CA, United StatesContract manufacturer, Manufacturer11May 18, 2012000api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer10January 27, 2015020api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Manufacturer, Specification developer5September 27, 2004030api.fda.gov
Quantimetrix Corp.Redondo Beach, CA, United StatesContract manufacturer, Manufacturer4May 10, 2012000api.fda.gov
Beckman Coulter, Inc.Chaska, MN, United StatesManufacturer3November 4, 2011000api.fda.gov
Bio-Rad Laboratories Inc.Irvine, CA, United StatesManufacturer3January 9, 2013000api.fda.gov
Bio-Rad Laboratories Inc.Irvine, CA, United StatesManufacturer3January 9, 2013000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer2July 6, 1998040api.fda.gov
Bionostics, Inc.Devens, MA, United StatesContract manufacturer, Manufacturer2February 10, 2011000api.fda.gov
Diasorin Inc.Stillwater, MN, United StatesContract manufacturer, Manufacturer2June 30, 2016000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer, Manufacturer, Manufacturer for export2February 18, 1993000api.fda.gov
Helena Laboratories, Corp.Beaumont, TX, United StatesManufacturer, Manufacturer for export2March 30, 1995010api.fda.gov
LGC Clinical Diagnostics, Inc.Cumberland Foreside, ME, United StatesManufacturer2June 14, 2013000api.fda.gov
Microgenics CorporationFremont, CA, United StatesContract manufacturer, Manufacturer, Manufacturer for export, Specification developer2August 16, 2004010api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer, Specification developer2May 7, 2004000api.fda.gov
Ortho-Clinical Diagnostics, Inc.San Diego, CA, United StatesSpecification developer2November 26, 1997000api.fda.gov
Qualigen, Inc.Carlsbad, CA, United StatesManufacturer2April 2, 2007000api.fda.gov
Quidel Corp.San Diego, CA, United StatesComplaint file establishment, Manufacturer2November 26, 1997000api.fda.gov
Quidel Cardiovascular Inc.San Diego, CA, United StatesManufacturer, Manufacturer for export2March 2, 2000000api.fda.gov
SA Scientific, LtdSan Antonio, TX, United StatesManufacturer2January 17, 1995000api.fda.gov
Acon Laboratories, Inc.San Diego, CA, United StatesContract manufacturer, Manufacturer, Specification developer1April 9, 2012000api.fda.gov
Analytical Control SystemsFishers, IN, United StatesManufacturer1April 20, 1994000api.fda.gov
Ascensia Diabetes Care US Inc.Parsippany, NJ, United StatesSpecification developer1September 23, 2015000api.fda.gov
Ascensia Diabetes Care US Inc.Valhalla, NY, United StatesComplaint file establishment, Specification developer1September 23, 2015000api.fda.gov
Biochemical Diagnostics, Inc.Edgewood, NY, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1March 29, 2005010api.fda.gov
Diazyme Laboratories, Inc.Poway, CA, United StatesManufacturer1October 29, 2004000api.fda.gov
Kova International IncGarden Grove, CA, United StatesManufacturer1January 26, 1993000api.fda.gov
LifeScan U.S. LLCMalvern, PA, United StatesSpecification developer1February 10, 2011000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Carlsbad, CA, United StatesManufacturer1June 22, 1993000api.fda.gov
Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC.Cortlandt Manor, NY, United StatesSpecification developer1April 29, 1992000api.fda.gov
QiagenGermantown, MD, United StatesManufacturer1February 2, 2004000api.fda.gov
Sekisui Diagnostics, LLCSan Diego, CA, United StatesManufacturer1December 6, 1995000api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesManufacturer, Manufacturer for export1July 17, 2015000api.fda.gov
Aalto Scientific Ltd.Eatonton, GA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Abbott Diabetes Care Inc.Alameda, CA, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesSpecification developer0000api.fda.gov
Abbott LaboratoriesAbbott Park, IL, United StatesSpecification developer0080api.fda.gov
AgamatrixDerry, NH, United StatesManufacturer, Specification developer0000api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Becton, Dickinson & Co.San Diego, CA, United StatesSpecification developer0000api.fda.gov
Becton, Dickinson & Co.Sparks, MD, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Bialex LabWichita Falls, TX, United StatesManufacturer0000api.fda.gov
Bio-Rad Laboratories, Inc.Woodinville, WA, United StatesContract manufacturer0000api.fda.gov
Biorex Labs LLCBroadview Heights, OH, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
BiometerPlus USA, Inc.Fremont, CA, United StatesManufacturer0000api.fda.gov
Care Living Diagnostics IncSouth Setauket, NY, United StatesSpecification developer0000api.fda.gov
Catachem, Inc.Oxford, CT, United StatesManufacturer0000api.fda.gov
Clinical Innovations, LLCMurray, UT, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cone Bioproducts Of Seguin LLCSeguin, TX, United StatesContract manufacturer0000api.fda.gov
CTK Biotech, Inc.Poway, CA, United StatesManufacturer0000api.fda.gov
Diagnostica Stago, Inc.Parsippany, NJ, United StatesManufacturer for export0000api.fda.gov
DiaSorin Molecular LLCCypress, CA, United StatesManufacturer0000api.fda.gov
ELITechGroup IncLogan, UT, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Fort Worth Diagnostics LLCFort Worth, TX, United StatesManufacturer0000api.fda.gov
Fujirebio Diagnostics, Inc.Malvern, PA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Fujirebio Diagnostics, Inc.Seguin, TX, United StatesManufacturer0000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
GL Diabetes CorporationSan Diego, CA, United StatesContract manufacturer0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Hologic, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Inova Diagnostics, Inc.San Diego, CA, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Instrumentation Laboratory Co.Bedford, MA, United StatesSpecification developer0000api.fda.gov
Kamiya Biomedical Company LLCTukwila, WA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
LGC Clinical Diagnostics, Inc.Milford, MA, United StatesManufacturer0000api.fda.gov
LGC Clinical Diagnostics, Inc.Gaithersburg, MD, United StatesManufacturer, Specification developer0000api.fda.gov
Maxim Biomedical Inc.Rockville, MD, United StatesContract manufacturer0000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer0000api.fda.gov
Mediusa Inc.Los Angeles, CA, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Nova Biomedical Corporation Diabetes ProductsBillerica, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer0000api.fda.gov
Nowdiagnostics, Inc.Springdale, AR, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer0000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer0000api.fda.gov
Osang LLCS Pasadena, CA, United StatesComplaint file establishment, Contract manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Precision Diabetes, Inc.Raleigh, NC, United StatesSpecification developer0000api.fda.gov
Princeton Biomeditech Corp.Monmouth Jct, NJ, United StatesManufacturer0000api.fda.gov
Princeton BioMeditech Corp.Plainsboro, NJ, United StatesManufacturer0000api.fda.gov
Princeton BioMeditech Corp.Skillman, NJ, United StatesManufacturer0000api.fda.gov
Rasimo Systems LLCRaleigh, NC, United StatesSpecification developer0000api.fda.gov
Roche Diabetes Care, Inc.Indianapolis, IN, United StatesManufacturer, Manufacturer for export, Repackager or relabeler, Specification developer0000api.fda.gov
RR Donnelley-Supply Chain SolutionsPlover, WI, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Rosie Connectivity Solutions, Inc.Savannah, GA, United StatesRemanufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Sequitur Health Corp.Phoenix, AZ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Spartronics Watertown LLCWatertown, SD, United StatesContract manufacturer0000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teladoc Health, Inc. - LewisvilleLewisville, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Telcare, LLCLinwood, PA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Trukera MedicalTemecula, CA, United StatesSpecification developer0000api.fda.gov
Victorch Meditek, Inc.San Diego, CA, United StatesManufacturer for export0000api.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.