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Data / Medical devices / Calibrator, Multi-Analyte Mixture / United States

FDA-registered makers of Calibrator, Multi-Analyte Mixture in the United States: 45 establishments

45 establishments in the United States are registered with the FDA to make Calibrator, Multi-Analyte Mixture (product code JIX). 22 have a 510(k) clearance or PMA approval on file and 10 have a recall event. FDA data exported November 2, 2026.

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Device
Calibrator, Multi-Analyte Mixture
Product code
JIX
Country
United States

Makers of Calibrator, Multi-Analyte Mixture in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Specification developer14December 18, 2015080api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer8December 18, 2015030api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesManufacturer, Specification developer7May 25, 2011040api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer, Manufacturer, Manufacturer for export6July 25, 2002000api.fda.gov
Cliniqa CorporationSan Marcos, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler4January 30, 2004000api.fda.gov
Microgenics CorporationFremont, CA, United StatesContract manufacturer, Manufacturer, Manufacturer for export4February 4, 2011000api.fda.gov
Verichem Laboratories, Inc.Providence, RI, United StatesContract manufacturer, Manufacturer4March 28, 2012000api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesSpecification developer3January 14, 2013000api.fda.gov
Carolina Liquid ChemistriesBrea, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer2June 5, 2009000api.fda.gov
Horiba Instruments IncorporatedCanton, MI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler2April 13, 2007010api.fda.gov
Kamiya Biomedical Company LLCTukwila, WA, United StatesManufacturer2December 27, 1999010api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1August 23, 1993010api.fda.gov
DIAMOND DIAGNOSTICS IncHolliston, MA, United StatesManufacturer1November 7, 2003000api.fda.gov
Instrumentation Laboratory Co.Orangeburg, NY, United StatesManufacturer1September 28, 2004000api.fda.gov
Infrared Laboratory Systems dba SYNERMEDWestfield, IN, United StatesManufacturer1April 21, 1994000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer1March 13, 2009000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer, Repackager or relabeler1December 10, 2002010api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1December 10, 2002070api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer1December 10, 2002000api.fda.gov
Phoenix Diagnostics, Inc.Natick, MA, United StatesManufacturer1November 15, 2002000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer, Repackager or relabeler1December 2, 1993000api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesSpecification developer1October 12, 2012010api.fda.gov
Beckman Coulter, Inc.Chaska, MN, United StatesManufacturer0000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Bio-Rad Laboratories, Inc.Woodinville, WA, United StatesContract manufacturer0000api.fda.gov
Bio-Rad Laboratories Inc.Irvine, CA, United StatesContract manufacturer0000api.fda.gov
Bio-Rad Laboratories Inc.Irvine, CA, United StatesContract manufacturer0000api.fda.gov
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Currier PlasticsAuburn, NY, United StatesContract manufacturer0000api.fda.gov
Diasorin Inc.Stillwater, MN, United StatesContract manufacturer0000api.fda.gov
Diazyme Laboratories, Inc.Poway, CA, United StatesManufacturer0000api.fda.gov
ELITechGroup IncLogan, UT, United StatesContract manufacturer0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Inova Diagnostics, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Remanufacturer0000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesManufacturer, Manufacturer for export, Remanufacturer0000api.fda.gov
Nypro Inc. (Chicago)Gurnee, IL, United StatesContract manufacturer0000api.fda.gov
Qualigen, Inc.Carlsbad, CA, United StatesManufacturer0000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Solomon Park Research Laboratories, Inc.Burien, WA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer0020api.fda.gov
Siemens Healthcare Diagnostics, Inc.Mishawaka, IN, United StatesManufacturer0000api.fda.gov
Sysmex America, Inc.Buffalo Grove, IL, United StatesContract manufacturer0000api.fda.gov
Sysmex America, Inc. - Vernon HillsVernon Hills, IL, United StatesContract manufacturer0000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer0000api.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.