Data / Medical devices / Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Respiratory Specimen Nucleic Acid Sars-Cov-2 Test (QQX): 12 FDA-registered makers in 3 countries
12 establishments in 3 countries are registered with the FDA to make Respiratory Specimen Nucleic Acid Sars-Cov-2 Test (product code QQX, Class 2, 21 CFR 866.3981). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on February 13, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QQX
- Device class
- 2
- Regulation
- 866.3981
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Sweden | 1 |
| Canada | 1 |
Makers of Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 | |
| Cepheid AB | SOLNA Stockholm, Sweden | Contract manufacturer | 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 | |
| GeneOhm Sciences Canada, ULC. | Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Springboard Manufacturing | Rancho Cordova, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 13, 2025. 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.