IDT DIAGNOSTICS CC · 89-08 · CHINA
For IDT DIAGNOSTICS CC, 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 Antigen; product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 05/28/2021; address is 271 De Goede Hoop , Noordhoek, CHINA, verified against its source on 2026-09-30.
- Firm
- IDT DIAGNOSTICS CC 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
- 271 De Goede Hoop , Noordhoek, CHINA verified
- Date published
- 05/28/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. verified
- Product
- COVID-19 Antigen verified
What the source says
IDT DIAGNOSTICS CC Date Published : 05/28/2021 271 De Goede Hoop , Noordhoek, 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: 05/28/2021 Desc: COVID-19 Antigen
— all from 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.