SHENZHEN WATMIND MEDICAL CO LTD · 89-08 · CHINA
For SHENZHEN WATMIND MEDICAL 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 SARS-CoV-2 IgG & IgM Ab Test Kit (Colloidal Gold); product code is 83 Q - - KO Reagent, coronavirus serological; date published is 04/20/2022; address is 8th Floor , Building A, No. 16-1, Jinhui Road, Jinsha Community, Kengzi Subdistrict; Pingshan District , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-30.
- Firm
- SHENZHEN WATMIND MEDICAL 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
- 8th Floor , Building A, No. 16-1, Jinhui Road, Jinsha Community, Kengzi Subdistrict; Pingshan District , Shenzhen, Guangdong CHINA verified
- Date published
- 04/20/2022 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- SARS-CoV-2 IgG & IgM Ab Test Kit (Colloidal Gold) verified
What the source says
SHENZHEN WATMIND MEDICAL CO LTD Date Published : 04/20/2022 8th Floor , Building A, No. 16-1, Jinhui Road, Jinsha Community, Kengzi Subdistrict; Pingshan District , Shenzhen, 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: SARS-CoV-2 IgG & IgM Ab Test Kit (Colloidal Gold)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html