BEIJING HOTGEN BIOTECH CO LTD · 89-08 · CHINA
For BEIJING HOTGEN 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 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 2026-09-16.
- 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 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)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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