Data / Medical devices / Multi-Analyte Respiratory Virus Antigen Detection Test / United States
FDA-registered makers of Multi-Analyte Respiratory Virus Antigen Detection Test in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Multi-Analyte Respiratory Virus Antigen Detection Test (product code SCA). 11 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
- Multi-Analyte Respiratory Virus Antigen Detection Test
- Product code
- SCA
- Country
- United States
Makers of Multi-Analyte Respiratory Virus Antigen Detection Test in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Acon Laboratories, Inc. | San Diego, CA, United States | Manufacturer, Specification developer | 2 | October 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Wondfo USA Co., Ltd. | San Diego, CA, United States | Complaint file establishment, Manufacturer | 2 | August 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Access Bio, Inc. | Monroe Township, NJ, United States | Manufacturer | 1 | August 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| CorDx, Inc. | Alpharetta, GA, United States | Manufacturer | 1 | October 14, 2026 | 0 | 0 | 0 | api.fda.gov |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 1 | October 7, 2024 | 0 | 0 | 0 | api.fda.gov |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | October 7, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nano-Ditech Corporation | Cranbury, NJ, United States | Manufacturer | 1 | June 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Osang LLC | S Pasadena, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | January 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| Princeton Biomeditech Corp. | Monmouth Jct, NJ, United States | Manufacturer | 1 | November 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Plainsboro, NJ, United States | Manufacturer | 1 | November 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Skillman, NJ, United States | Manufacturer | 1 | November 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Victorch Meditek, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| iHealth Manufacturing Inc | Irwindale, 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.