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

For HANGZHOU LAIHE 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 QuickKit Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold Method) | LYHER Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold); product code is 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 05/28/2021; address is Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road, Xixing Street, Binjiang District , Hangzhou, Zhejiang CHINA, verified against its source on 2026-09-16.

- **Firm:** HANGZHOU LAIHE 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:** Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road, Xixing Street, Binjiang District , Hangzhou, Zhejiang CHINA _(verified: appears in the quote below)_
- **Date published:** 05/28/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. _(verified: each item appears in the quote below)_
- **Product:** QuickKit Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold Method) | LYHER Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) _(verified: each item appears in the quote below)_

## What the source says

> HANGZHOU LAIHE BIOTECH CO,. LTD. Date Published : 05/28/2021 Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road, Xixing Street, Binjiang District , Hangzhou, Zhejiang CHINA 83 Q - - KP Coronavirus antigen detection test system. Date Published: 05/28/2021 Desc: QuickKit Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold Method) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/04/2022 Desc: LYHER Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)

## 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/).