Data / Medical devices / Respiratory Specimen Nucleic Acid Sars-Cov-2 Test / United States
FDA-registered makers of Respiratory Specimen Nucleic Acid Sars-Cov-2 Test in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Respiratory Specimen Nucleic Acid Sars-Cov-2 Test (product code QQX). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
- Product code
- QQX
- Country
- United States
Makers of Respiratory Specimen Nucleic Acid Sars-Cov-2 Test in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| BioFire Defense, LLC | Salt Lake City, UT, United States | Manufacturer | 2 | July 25, 2022 | 0 | 0 | 0 | api.fda.gov |
| Cepheid | Sunnyvale, CA, United States | Manufacturer, Specification developer | 2 | January 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Cepheid | Lodi, CA, United States | Manufacturer | 2 | January 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hologic, Inc. | San Diego, CA, United States | Manufacturer, Manufacturer for export | 1 | February 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| Life Technologies Corporation | Pleasanton, CA, United States | Complaint file establishment, Manufacturer | 1 | July 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | Manufacturer | 1 | October 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Pleasanton, CA, United States | Specification developer | 1 | October 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostics For The Real World, Ltd. | Morgan Hill, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Springboard Manufacturing | Rancho Cordova, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.