# QINGDAO HIGHTOP BIOTECH CO., LTD. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For QINGDAO HIGHTOP 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 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 2026-09-16.

- **Firm:** QINGDAO HIGHTOP BIOTECH CO., LTD. _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** No. 369 Hedong Road , Hi-Tech Industrial Development Zone , Qingdao, Shandong CHINA _(verified: appears in the quote below)_
- **Date published:** 04/20/2022 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological _(verified: appears in the quote below)_
- **Product:** SARS-CoV-2 IgM/IgG Antibody Rapid Test _(verified: appears in the quote below)_

## 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 83 Q - - KO Reagent, coronavirus serological Date Published: 04/20/2022 Desc: SARS-CoV-2 IgM/IgG Antibody Rapid Test

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).