Data / Medical devices / Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings / United States
FDA-registered makers of Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings (product code QVF). 9 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
- Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
- Product code
- QVF
- Country
- United States
Makers of Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | San Diego, CA, United States | Complaint file establishment, Specification developer | 2 | December 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Carlsbad, CA, United States | Manufacturer | 2 | December 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Quidel Corp. | San Diego, CA, United States | Complaint file establishment, Manufacturer | 2 | December 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | San Diego, CA, United States | Specification developer | 1 | June 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer | 1 | June 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| CorDx, Inc. | Alpharetta, GA, United States | Manufacturer | 1 | June 1, 2026 | 0 | 0 | 0 | api.fda.gov |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 1 | April 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Inbios International, Inc. | Seattle, WA, United States | Manufacturer | 1 | August 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nano-Ditech Corporation | Cranbury, NJ, United States | Manufacturer | 1 | January 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Scantibodies Laboratory Inc. | San Diego, 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.