Data / Medical devices / Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus / United States
FDA-registered makers of Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus (product code GQG). 10 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.
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- Device
- Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- Product code
- GQG
- Country
- United States
Makers of Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | San Diego, CA, United States | Specification developer | 3 | November 15, 2013 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer | 3 | November 15, 2013 | 0 | 1 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | San Diego, CA, United States | Specification developer | 3 | February 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Carlsbad, CA, United States | Manufacturer | 3 | February 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Quidel Corp. | San Diego, CA, United States | Complaint file establishment, Manufacturer | 3 | February 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Abbott Diagnostics Scarborough, Inc. | Scarborough, ME, United States | Manufacturer | 1 | October 21, 2003 | 0 | 2 | 0 | api.fda.gov |
| Abbott Diagnostics Scarborough, Inc. | Westbrook, ME, United States | Manufacturer | 1 | October 21, 2003 | 0 | 0 | 0 | api.fda.gov |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | November 20, 2002 | 0 | 0 | 0 | api.fda.gov |
| Nano-Ditech Corporation | Cranbury, NJ, United States | Manufacturer | 1 | July 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| Sekisui Diagnostics, LLC | San Diego, CA, United States | Manufacturer for export, Repackager or relabeler | 1 | July 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| CTK Biotech, Inc. | Poway, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keva Inc. | Blaine, WA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Planet Innovation Products, Inc. | Irvine, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remel, Inc. | Lenexa, KS, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SA Scientific, Ltd | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 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.