ZHUHAI LITUO BIOTECHNOLOGY CO.,LTD · 89-08 · CHINA
For ZHUHAI LITUO BIOTECHNOLOGY 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 COVID-19 Antigen Detection Kit (Collodial Gold); product code is 83 Q - - KO Reagent, coronavirus serological; date published is 05/28/2021; address is No. 35 Yongan Three Road , Jinwan District Hongqi Town , Zhuhai, Guangdong CHINA, verified against its source on 2026-09-30.
- Firm
- ZHUHAI LITUO BIOTECHNOLOGY 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
- No. 35 Yongan Three Road , Jinwan District Hongqi Town , Zhuhai, Guangdong CHINA verified
- Date published
- 05/28/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- COVID-19 Antigen Detection Kit (Collodial Gold) verified
What the source says
ZHUHAI LITUO BIOTECHNOLOGY CO.,LTD Date Published : 05/28/2021 No. 35 Yongan Three Road , Jinwan District Hongqi Town , Zhuhai, Guangdong 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.
Product code and Product
83 Q - - KO Reagent, coronavirus serological Date Published: 05/28/2021 Desc: COVID-19 Antigen Detection Kit (Collodial Gold)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html