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Data / Medical devices / Clinical Sample Concentrator / United States

FDA-registered makers of Clinical Sample Concentrator in the United States: 25 establishments

25 establishments in the United States are registered with the FDA to make Clinical Sample Concentrator (product code JJH). 0 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
Clinical Sample Concentrator
Product code
JJH
Country
United States

Makers of Clinical Sample Concentrator in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Abbott Molecular, Inc.Des Plaines, IL, United StatesManufacturer, Manufacturer for export, Specification developer0050api.fda.gov
Apostle Inc.Pleasanton, CA, United StatesManufacturer0000api.fda.gov
Abbott Molecular Distribution CenterItasca, IL, United StatesManufacturer for export0000api.fda.gov
Becton, Dickinson & Co.Sparks, MD, United StatesComplaint file establishment, Manufacturer, Specification developer0010api.fda.gov
Biomiga, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
CepheidSunnyvale, CA, United StatesManufacturer for export0000api.fda.gov
Cura Diagnostics Inc.Woburn, MA, United StatesManufacturer0000api.fda.gov
CalibreScientific US, Inc.Vancouver, WA, United StatesManufacturer0000api.fda.gov
Entrogen, IncWoodland Hills, CA, United StatesSpecification developer0000api.fda.gov
Hamilton Co.Reno, NV, United StatesContract manufacturer0000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Hologic, Inc.San Diego, CA, United StatesManufacturer, Manufacturer for export0000api.fda.gov
Life Technologies CorporationAustin, TX, United StatesSpecification developer0000api.fda.gov
Life Technologies CorporationCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Life Technologies CorporationGuilford, CT, United StatesSpecification developer0000api.fda.gov
Life Technologies CorporationFrederick, MD, United StatesManufacturer0000api.fda.gov
Luminex CorporationAustin, TX, United StatesManufacturer0000api.fda.gov
Magnet Medical Systems LLCSouthlake, TX, United StatesSpecification developer0000api.fda.gov
Omega Bio-TekNorcross, GA, United StatesManufacturer for export0000api.fda.gov
Promega CorporationMadison, WI, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Roche Molecular Systems, Inc.Pleasanton, CA, United StatesSpecification developer0000api.fda.gov
Vivaproducts, Inc.Littleton, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
VWR Chemicals, LLCSolon, OH, United StatesContract manufacturer0000api.fda.gov
Veracyte, Inc.S San Fran, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Zeptometrix LLC.Buffalo, NY, 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.