# SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING CO, LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING 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 True-Dot Novel Coronavirus (2019-nCoV) IgM/IgG rapid antibody detection kit; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 03/11/2021; address is Fl R , 4th 71-5 Xintian Ave , Shenzhen, CHINA, verified against its source on 2026-09-16.

- **Firm:** SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING 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:** Fl R , 4th 71-5 Xintian Ave , Shenzhen, CHINA _(verified: appears in the quote below)_
- **Date published:** 03/11/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological _(verified: appears in the quote below)_
- **Product:** True-Dot Novel Coronavirus (2019-nCoV) IgM/IgG rapid antibody detection kit _(verified: appears in the quote below)_

## What the source says

> SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING CO, LTD Date Published : 03/11/2021 Fl R , 4th 71-5 Xintian Ave , Shenzhen, CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 03/11/2021 Desc: True-Dot Novel Coronavirus (2019-nCoV) IgM/IgG rapid antibody detection kit

## 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/).