Guangzhou Wondfo Biotech Co., Ltd. · 89-08 · CHINA
For Guangzhou Wondfo Biotech Co., Ltd., import alert is 89-08; country is CHINA; 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)"; 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
83 Q - - KO Reagent, coronavirus serological Date Published: 04/20/2022 Desc: Wondfo SARSCoV-2 Antibody Test (Lateral Flow Method
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html