HANGZHOU LAIHE BIOTECH CO,. LTD. · 89-08 · CHINA
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
- 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
- Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road, Xixing Street, Binjiang District , Hangzhou, Zhejiang CHINA verified
- Date published
- 05/28/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- QuickKit Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold Method) | LYHER Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) each item verified
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)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html