HANGZHOU LAIHE BIOTECH CO,. LTD. · 89-08 · CHINA

For HANGZHOU LAIHE 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 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 2026-09-30.

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

— 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.

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.