Core Technology Co. Ltd. · 89-08 · CHINA
For Core Technology 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 Coretests COVID-19 IgM/IgG Ab Test | COVID-19 IgM/IgG Ab Test; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 08/31/2021; address is Building C Room 100 , 29 Life Park Rd; Changping District , Beijing, Beijing CHINA, verified against its source on 2026-09-16.
- Firm
- Core Technology 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
- Building C Room 100 , 29 Life Park Rd; Changping District , Beijing, Beijing CHINA verified
- Date published
- 08/31/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- Coretests COVID-19 IgM/IgG Ab Test | COVID-19 IgM/IgG Ab Test each item verified
What the source says
Core Technology Co. Ltd. Date Published : 08/31/2021 Building C Room 100 , 29 Life Park Rd; Changping District , Beijing, Beijing CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 08/31/2021 Desc: Coretests COVID-19 IgM/IgG Ab Test 83 Q - - KO Reagent, coronavirus serological Date Published: 08/31/2021 Desc: COVID-19 IgM/IgG Ab Test
— 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.