Data / Medical devices / Coronavirus Antigen Detection Test System. / South Korea
FDA-registered makers of Coronavirus Antigen Detection Test System. in South Korea: 5 establishments
5 establishments in South Korea are registered with the FDA to make Coronavirus Antigen Detection Test System. (product code QKP). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Coronavirus Antigen Detection Test System.
- Product code
- QKP
- Country
- South Korea
Makers of Coronavirus Antigen Detection Test System. in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Diagnostics Korea Inc. | Yongin-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genbody Inc. | Cheonan Chungnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OSANG Healthcare CO., LTD. | ANYANG Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SD Biosensor, Inc. | Suwon-si Gyeonggi, South Korea | Specification developer | 0 | 0 | 2 | 2 | api.fda.gov | |
| SD Biosensor, Inc. | Cheongju-si Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.