Guangzhou Wondfo Biotech Co., Ltd. · 89-08 · CHINA
For Guangzhou Wondfo Biotech Co., Ltd. · 89-08 · CHINA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CHINA; product is Wondfo SARSCoV-2 Antibody Test (Lateral Flow Method; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 04/20/2022; address is 501 Rom, 5f Self-Edited Building 1 , No. 8 Lizhishan Road; Huangpu District Science City , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.
- Firm
- Guangzhou Wondfo Biotech Co., Ltd. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CHINA verified
- Address
- 501 Rom, 5f Self-Edited Building 1 , No. 8 Lizhishan Road; Huangpu District Science City , Guangzhou, Guangdong CHINA verified
- Date published
- 04/20/2022 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- Wondfo SARSCoV-2 Antibody Test (Lateral Flow Method verified
What the source says
Guangzhou Wondfo Biotech Co., Ltd. Date Published : 04/20/2022 501 Rom, 5f Self-Edited Building 1 , No. 8 Lizhishan Road; Huangpu District Science City , Guangzhou, Guangdong CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 04/20/2022 Desc: Wondfo SARSCoV-2 Antibody Test (Lateral Flow Method
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.