Data / Medical devices / Antigens, All Groups, Streptococcus Spp. / China
FDA-registered makers of Antigens, All Groups, Streptococcus Spp. in China: 9 establishments
9 establishments in China are registered with the FDA to make Antigens, All Groups, Streptococcus Spp. (product code GTY). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Antigens, All Groups, Streptococcus Spp.
- Product code
- GTY
- Country
- China
Makers of Antigens, All Groups, Streptococcus Spp. in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| BD Rapid Diagnostics (Suzhou) Co. Ltd. | China (Jiangsu) Pilot Free Trade Zone Suzhou Area, China | Manufacturer | 1 | February 6, 2013 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou Guangdong, China | Complaint file establishment, Manufacturer | 1 | January 31, 2014 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Wondfo Biotech Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 1 | January 31, 2014 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 1 | April 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 1 | April 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 1 | April 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| Abon Biopharm (hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | Nantong Jiangsu, China | 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 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.