Skip to the page
Get started free

Data / Medical devices / Instrumentation For Clinical Multiplex Test Systems / United States

FDA-registered makers of Instrumentation For Clinical Multiplex Test Systems in the United States: 28 establishments

28 establishments in the United States are registered with the FDA to make Instrumentation For Clinical Multiplex Test Systems (product code NSU). 5 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers of this device in the United StatesWatch these makers
Device
Instrumentation For Clinical Multiplex Test Systems
Product code
NSU
Country
United States

Makers of Instrumentation For Clinical Multiplex Test Systems in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Luminex CorporationAustin, TX, United StatesContract manufacturer, Manufacturer3January 10, 2014000api.fda.gov
Affymetrix, Inc.Pleasanton, CA, United StatesManufacturer, Manufacturer for export1December 23, 2004010api.fda.gov
BioFire Defense, LLCSalt Lake City, UT, United StatesManufacturer, Repackager or relabeler1January 30, 2015000api.fda.gov
BioFire Diagnostics, LLCSalt Lake City, UT, United StatesManufacturer1January 30, 2015020api.fda.gov
Genmark Diagnostics, Inc.Carlsbad, CA, United StatesManufacturer1June 9, 2017000api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesManufacturer for export0000api.fda.gov
Autogenomics, IncorporatedCarlsbad, CA, United StatesManufacturer0000api.fda.gov
Applied BioCode, Inc.Santa Fe Springs, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Becton, Dickinson & Co.Sparks, MD, United StatesComplaint file establishment, Manufacturer, Specification developer0010api.fda.gov
Bio-Rad Laboratories, Inc.Woodinville, WA, United StatesManufacturer0000api.fda.gov
Bioarray Solutions LimitedWarren, NJ, United StatesManufacturer, Manufacturer for export0000api.fda.gov
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
CepheidSunnyvale, CA, United StatesManufacturer0000api.fda.gov
CTK Biotech, Inc.Poway, CA, United StatesManufacturer0000api.fda.gov
CepheidLodi, CA, United StatesManufacturer0000api.fda.gov
Fluxergy Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Gold Standard Diagnostics, LLCDavis, CA, United StatesManufacturer for export0000api.fda.gov
Hologic, Inc.San Diego, CA, United StatesManufacturer0040api.fda.gov
Inanovate IncSioux Falls, SD, United StatesManufacturer0000api.fda.gov
Inova Diagnostics, Inc.San Diego, CA, United StatesManufacturer, Specification developer0000api.fda.gov
KORVIS LLC (DBA Ascential Medical & Life Sciences)Corvallis, OR, United StatesManufacturer for export0000api.fda.gov
Luminex CorporationNorthbrook, IL, United StatesManufacturer0010api.fda.gov
Nuclein, LLCAustin, TX, United StatesManufacturer0000api.fda.gov
Nuclein, LLCAustin, TX, United StatesManufacturer0020api.fda.gov
Plexus Corp.Buffalo Grove, IL, United StatesContract manufacturer0000api.fda.gov
Plexus Corp.Neenah, WI, United StatesContract manufacturer0000api.fda.gov
Roche Molecular Systems, Inc.Branchburg, NJ, United StatesManufacturer, Specification developer0010api.fda.gov
Roche Molecular Systems, Inc.Pleasanton, CA, United StatesSpecification developer0000api.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.