Shenzhen Microprofit Biotech Co., Ltd. · 89-08 · CHINA
For Shenzhen Microprofit 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 COVID-19 DART; product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 06/22/2021; address is Technology Centre Room 1001 , Of Unit 1, Building 2, Hongchuang; Nanshan District , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-30.
- Firm
- Shenzhen Microprofit 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
- Technology Centre Room 1001 , Of Unit 1, Building 2, Hongchuang; Nanshan District , Shenzhen, Guangdong CHINA verified
- Date published
- 06/22/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. verified
- Product
- COVID-19 DART verified
What the source says
Shenzhen Microprofit Biotech Co., Ltd. Date Published : 06/22/2021 Technology Centre Room 1001 , Of Unit 1, Building 2, Hongchuang; Nanshan District , Shenzhen, 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 - - KP Coronavirus antigen detection test system. Date Published: 06/22/2021 Desc: COVID-19 DART
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html