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Data / Medical devices / Multi-Analyte Controls, All Kinds (Assayed) / United States

FDA-registered makers of Multi-Analyte Controls, All Kinds (Assayed) in the United States: 62 establishments

62 establishments in the United States are registered with the FDA to make Multi-Analyte Controls, All Kinds (Assayed) (product code JJY). 32 have a 510(k) clearance or PMA approval on file and 11 have a recall event. FDA data exported November 2, 2026.

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Device
Multi-Analyte Controls, All Kinds (Assayed)
Product code
JJY
Country
United States

Makers of Multi-Analyte Controls, All Kinds (Assayed) in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Bio-Rad Laboratories Inc.Irvine, CA, United StatesManufacturer48January 10, 2017010api.fda.gov
Bio-Rad Laboratories Inc.Irvine, CA, United StatesManufacturer48January 10, 2017000api.fda.gov
Cliniqa CorporationSan Marcos, CA, United StatesContract manufacturer, Manufacturer27January 23, 2012000api.fda.gov
LGC Clinical Diagnostics, Inc.Cumberland Foreside, ME, United StatesManufacturer9June 25, 2009000api.fda.gov
Bionostics, Inc.Devens, MA, United StatesContract manufacturer, Manufacturer7June 19, 2000000api.fda.gov
Helena Laboratories, Corp.Beaumont, TX, United StatesManufacturer7October 7, 2013010api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer6March 5, 2001010api.fda.gov
DIAMOND DIAGNOSTICS IncHolliston, MA, United StatesManufacturer6April 17, 2013000api.fda.gov
Horiba Instruments IncorporatedCanton, MI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler6April 11, 2007030api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer6August 27, 2010000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler4September 23, 2005000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer4December 19, 2003020api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer3November 4, 1998000api.fda.gov
Quantimetrix Corp.Redondo Beach, CA, United StatesManufacturer3April 8, 1997010api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler2September 17, 2008000api.fda.gov
Kamiya Biomedical Company LLCTukwila, WA, United StatesManufacturer2September 29, 1998000api.fda.gov
LGC Clinical Diagnostics, Inc.Milford, MA, United StatesManufacturer2August 12, 1997000api.fda.gov
Opti Medical Systems Inc.Roswell, GA, United StatesManufacturer, Specification developer2June 19, 2000000api.fda.gov
Phoenix Diagnostics, Inc.Natick, MA, United StatesManufacturer2September 6, 1991000api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesSpecification developer2April 8, 1997000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer2October 4, 1994000api.fda.gov
Utak Laboratories, Inc.Valencia, CA, United StatesManufacturer2October 6, 1988010api.fda.gov
Alere San Diego, Inc.San Diego, CA, United StatesSpecification developer1December 21, 2010040api.fda.gov
Bialex LabWichita Falls, TX, United StatesManufacturer1December 9, 2004000api.fda.gov
Hemagen Diagnostics, Inc.Baltimore, MD, United StatesManufacturer1May 23, 1986000api.fda.gov
More Diagnostics Inc.Los Osos, CA, United StatesManufacturer1March 18, 2005000api.fda.gov
Microgenics CorporationFremont, CA, United StatesContract manufacturer, Manufacturer, Manufacturer for export1December 21, 2001060api.fda.gov
Polymer Technology SystemsWhitestown, IN, United StatesManufacturer1August 21, 2002000api.fda.gov
Qualigen, Inc.Carlsbad, CA, United StatesManufacturer1March 8, 2013000api.fda.gov
Quidel Cardiovascular Inc.San Diego, CA, United StatesManufacturer, Manufacturer for export1December 7, 2007000api.fda.gov
Scantibodies Laboratory, Inc.Santee, CA, United StatesManufacturer1February 14, 1996000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer, Repackager or relabeler1September 25, 1995000api.fda.gov
Aalto Scientific Ltd.Eatonton, GA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Ansh Labs, LLCWebster, TX, United StatesManufacturer0000api.fda.gov
Axiom Diagnostics, Inc.Tampa, FL, United StatesManufacturer0000api.fda.gov
Access Bio, Inc.Monroe Township, NJ, 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
Bioresource TechnologyWeston, FL, United StatesContract manufacturer0000api.fda.gov
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Cone Bioproducts Of Seguin LLCSeguin, TX, United StatesContract manufacturer0000api.fda.gov
Currier PlasticsAuburn, NY, United StatesContract manufacturer0000api.fda.gov
Diasorin Inc.Stillwater, MN, United StatesContract manufacturer, Specification developer0000api.fda.gov
ELITechGroup IncLogan, UT, United StatesContract manufacturer, Manufacturer0010api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
InflammatixSunnyvale, CA, United StatesManufacturer0000api.fda.gov
Inova Diagnostics, Inc.San Diego, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Instrumentation Laboratory Co.Bedford, MA, United StatesManufacturer0000api.fda.gov
Instrumentation Laboratory Co.Orangeburg, NY, United StatesManufacturer0000api.fda.gov
Lumos Diagnostics, Inc.Carlsbad, CA, United StatesManufacturer0000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer0000api.fda.gov
Monobind, Inc.Lake Forest, CA, United StatesManufacturer0000api.fda.gov
Nova Biomedical Corporation Diabetes ProductsBillerica, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export0000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesContract manufacturer, Manufacturer, Manufacturer for export0000api.fda.gov
Nypro Inc. (Chicago)Gurnee, IL, United StatesContract manufacturer0000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer, Repackager or relabeler0010api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer0000api.fda.gov
R & D Systems, Inc.Minneapolis, MN, United StatesManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Verax Biomedical IncorporatedWestborough, MA, 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.