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Data / Medical devices / Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents / United States

FDA-registered makers of Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents in the United States: 21 establishments

21 establishments in the United States are registered with the FDA to make Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents (product code QOF). 17 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.

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Device
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Product code
QOF
Country
United States

Makers of Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
BioFire Diagnostics, LLCSalt Lake City, UT, United StatesManufacturer, Manufacturer for export7September 22, 2026060api.fda.gov
CepheidSunnyvale, CA, United StatesManufacturer, Specification developer5September 25, 2026000api.fda.gov
CepheidLodi, CA, United StatesManufacturer5September 25, 2026000api.fda.gov
Roche Molecular Systems, Inc.Branchburg, NJ, United StatesManufacturer4July 31, 2025000api.fda.gov
Roche Molecular Systems, Inc.Pleasanton, CA, United StatesSpecification developer4July 31, 2025000api.fda.gov
DiaSorin Molecular LLCCypress, CA, United StatesManufacturer3December 23, 2025000api.fda.gov
Hologic, Inc.San Diego, CA, United StatesManufacturer, Manufacturer for export3November 15, 2024010api.fda.gov
Baebies Inc.Durham, NC, United StatesManufacturer2September 11, 2026000api.fda.gov
Abbott Molecular, Inc.Des Plaines, IL, United StatesManufacturer, Manufacturer for export1February 14, 2025000api.fda.gov
Autonomous Medical Devices IncorporatedSanta Ana, CA, United StatesComplaint file establishment, Manufacturer1June 12, 2026000api.fda.gov
Abbott Molecular Distribution CenterItasca, IL, United StatesManufacturer1February 14, 2025000api.fda.gov
Becton, Dickinson & Co.Sparks, MD, United StatesComplaint file establishment, Manufacturer, Specification developer1July 31, 2023000api.fda.gov
Life Technologies CorporationS San Fran, CA, United StatesSpecification developer1January 8, 2025000api.fda.gov
Life Technologies CorporationPleasanton, CA, United StatesComplaint file establishment, Manufacturer1January 8, 2025000api.fda.gov
Luminex CorporationNorthbrook, IL, United StatesManufacturer1March 1, 2024000api.fda.gov
Nuclein, LLCAustin, TX, United StatesManufacturer1December 20, 2024000api.fda.gov
Nuclein, LLCAustin, TX, United StatesManufacturer1December 20, 2024010api.fda.gov
Diagnostics For The Real World, Ltd.Morgan Hill, CA, United StatesManufacturer for export0000api.fda.gov
Genmark Diagnostics, Inc.Carlsbad, CA, United StatesManufacturer for export0000api.fda.gov
Springboard ManufacturingRancho Cordova, CA, United StatesContract manufacturer0000api.fda.gov
The Dot Printer Inc.Irvine, CA, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov

Updated November 3, 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.