QINGDAO HIGHTOP BIOTECH CO., LTD. · 89-08 · CHINA
For QINGDAO HIGHTOP 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 SARS-CoV-2 IgM/IgG Antibody Rapid Test; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 04/20/2022; address is No. 369 Hedong Road , Hi-Tech Industrial Development Zone , Qingdao, Shandong CHINA, verified against its source on 2026-09-30.
- Firm
- QINGDAO HIGHTOP 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
- No. 369 Hedong Road , Hi-Tech Industrial Development Zone , Qingdao, Shandong CHINA verified
- Date published
- 04/20/2022 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- SARS-CoV-2 IgM/IgG Antibody Rapid Test verified
What the source says
QINGDAO HIGHTOP BIOTECH CO., LTD. Date Published : 04/20/2022 No. 369 Hedong Road , Hi-Tech Industrial Development Zone , Qingdao, Shandong 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 IgM/IgG Antibody Rapid Test
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html