SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING CO, LTD · 89-08 · CHINA
For SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING 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 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 2026-09-16.
- 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 83 Q - - KO Reagent, coronavirus serological Date Published: 03/11/2021 Desc: True-Dot Novel Coronavirus (2019-nCoV) IgM/IgG rapid antibody detection kit
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.