Core Technology Co. Ltd. · 89-08 · CHINA
For Core Technology 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 IgM/IgG Ab Test | Coretests 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 2026-09-30.
- 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
- COVID-19 IgM/IgG Ab Test | Coretests 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
— accessdata.fda.gov, retrieved 2026-09-22
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: 08/31/2021 Desc: COVID-19 IgM/IgG Ab Test 83 Q - - KO Reagent, coronavirus serological Date Published: 08/31/2021 Desc: Coretests COVID-19 IgM/IgG Ab Test
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html