BEIJING HOTGEN BIOTECH CO LTD · 89-08 · CHINA
For BEIJING HOTGEN 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 Novel Coronavirus (SARS-CoV-2) Neutralizing Antibody Test | Novel Coronavirus 2019- nCoV Antigen Test (Colloidal Gold); product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 07/27/2021; address is 6th, 7th and 9th Buildings , No. 55 Qingfeng West Road, Daxing District , Beijing, CHINA, verified against its source on 2026-09-30.
- Firm
- BEIJING HOTGEN 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
- 6th, 7th and 9th Buildings , No. 55 Qingfeng West Road, Daxing District , Beijing, CHINA verified
- Date published
- 07/27/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- Novel Coronavirus (SARS-CoV-2) Neutralizing Antibody Test | Novel Coronavirus 2019- nCoV Antigen Test (Colloidal Gold) each item verified
What the source says
BEIJING HOTGEN BIOTECH CO LTD Date Published : 07/27/2021 6th, 7th and 9th Buildings , No. 55 Qingfeng West Road, Daxing District , Beijing, 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: 08/31/2021 Desc: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibody Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: Novel Coronavirus 2019- nCoV Antigen Test (Colloidal Gold)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html