SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING CO, LTD · 89-08 · CHINA
For SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING 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 True-Dot Novel Coronavirus (2019-nCoV) IgM/IgG rapid antibody detection kit; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 03/11/2021; address is Fl R , 4th 71-5 Xintian Ave , Shenzhen, CHINA, verified against its source on 2026-09-30.
- Firm
- SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING 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
- Fl R , 4th 71-5 Xintian Ave , Shenzhen, CHINA verified
- Date published
- 03/11/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- True-Dot Novel Coronavirus (2019-nCoV) IgM/IgG rapid antibody detection kit verified
What the source says
SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING CO, LTD Date Published : 03/11/2021 Fl R , 4th 71-5 Xintian Ave , Shenzhen, 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: 03/11/2021 Desc: True-Dot Novel Coronavirus (2019-nCoV) IgM/IgG rapid antibody detection kit
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html