Data / Medical devices / Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings (QVF): 17 FDA-registered makers in 3 countries
17 establishments in 3 countries 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, Class 2, 21 CFR 866.3982). 12 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on September 4, 2026, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- QVF
- Device class
- 2
- Regulation
- 866.3982
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| China | 4 |
| Mexico | 3 |
Makers of Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
| BD Rapid Diagnostics (Suzhou) Co. Ltd. | China (Jiangsu) Pilot Free Trade Zone Suzhou Area, China | Manufacturer | 1 | June 16, 2025 | 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 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou Guangdong, China | Complaint file establishment, Manufacturer | 1 | October 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Wondfo Biotech Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 1 | October 22, 2025 | 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 |
| Laboratorios Scantibodies S.A. De C.V. | TECATE Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laboratorios Scantibodies, S.A. de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laboratorios Scantibodies, S.A. de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scantibodies Laboratory Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 4, 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.