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Data / Medical devices / Respiratory Virus Panel Nucleic Acid Assay System / United States

FDA-registered makers of Respiratory Virus Panel Nucleic Acid Assay System in the United States: 20 establishments

20 establishments in the United States are registered with the FDA to make Respiratory Virus Panel Nucleic Acid Assay System (product code OCC). 14 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 2, 2026.

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Device
Respiratory Virus Panel Nucleic Acid Assay System
Product code
OCC
Country
United States

Makers of Respiratory Virus Panel Nucleic Acid Assay System in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
CepheidSunnyvale, CA, United StatesManufacturer, Specification developer6August 15, 2018000api.fda.gov
CepheidLodi, CA, United StatesManufacturer5August 15, 2018000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Athens, OH, United StatesComplaint file establishment, Manufacturer4October 16, 2017000api.fda.gov
Abbott Diagnostics Scarborough, Inc.Scarborough, ME, United StatesManufacturer, Specification developer3September 29, 2017040api.fda.gov
Hologic, Inc.San Diego, CA, United StatesManufacturer3May 5, 2023010api.fda.gov
Applied BioCode, Inc.Santa Fe Springs, CA, United StatesComplaint file establishment, Manufacturer2May 1, 2026000api.fda.gov
DiaSorin Molecular LLCCypress, CA, United StatesManufacturer2August 22, 2020041api.fda.gov
Luminex CorporationAustin, TX, United StatesComplaint file establishment, Manufacturer, Remanufacturer2December 17, 2015010api.fda.gov
Roche Molecular Systems, Inc.Branchburg, NJ, United StatesManufacturer, Manufacturer for export2July 25, 2016030api.fda.gov
Roche Molecular Systems, Inc.Pleasanton, CA, United StatesSpecification developer2July 25, 2016000api.fda.gov
Abbott Diagnostics Scarborough, Inc.Portland, ME, United StatesManufacturer, Repackager or relabeler1June 13, 2014000api.fda.gov
BioFire Diagnostics, LLCSalt Lake City, UT, United StatesManufacturer1February 8, 2016020api.fda.gov
Genmark Diagnostics, Inc.Carlsbad, CA, United StatesManufacturer1June 9, 2017000api.fda.gov
Luminex CorporationNorthbrook, IL, United StatesComplaint file establishment, Manufacturer1September 4, 2015020api.fda.gov
Abbott Molecular, Inc.Des Plaines, IL, United StatesManufacturer for export0000api.fda.gov
Autonomous Medical Devices IncorporatedSanta Ana, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
BiogxBirmingham, AL, United StatesManufacturer for export0000api.fda.gov
DIAMOND DIAGNOSTICS IncHolliston, MA, United StatesContract manufacturer0000api.fda.gov
Enercon TechnologiesGray, ME, United StatesContract manufacturer0000api.fda.gov
Springboard ManufacturingRancho Cordova, CA, United StatesContract manufacturer0000api.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.