GOLDSITE DIAGNOSTICS INC · 89-08 · CHINA
For GOLDSITE DIAGNOSTICS INC, 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 Kit; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 05/14/2021; address is No. 103c, 503c & 504d, Technology Building & No. 3a & 4a, Technology Building Annex, Zhaoshang Sub-District, N , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-30.
- Firm
- GOLDSITE DIAGNOSTICS INC 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
- No. 103c, 503c & 504d, Technology Building & No. 3a & 4a, Technology Building Annex, Zhaoshang Sub-District, N , Shenzhen, Guangdong CHINA verified
- Date published
- 05/14/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- SARS-CoV-2 IgG/IgM Kit verified
What the source says
GOLDSITE DIAGNOSTICS INC Date Published : 05/14/2021 No. 103c, 503c & 504d, Technology Building & No. 3a & 4a, Technology Building Annex, Zhaoshang Sub-District, N , 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: 05/14/2021 Desc: SARS-CoV-2 IgG/IgM Kit
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html