ICARE DIAGNOSTICS INTERNATIONALCO, LTD · 89-08 · TAIWAN
For ICARE DIAGNOSTICS INTERNATIONALCO, LTD · 89-08 · TAIWAN, 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 TAIWAN; product is iCareDx PSS-1 RT- PCR Testing System for SARS-CoV-2 using saliva; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 11/24/2021; address is 15 F , Beixin Rd, Sec 3; No 207-3 Xindian Dist , New Taipei City, TAIWAN, verified against its source on 2026-09-16.
- Firm
- ICARE DIAGNOSTICS INTERNATIONALCO, 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
- TAIWAN verified
- Address
- 15 F , Beixin Rd, Sec 3; No 207-3 Xindian Dist , New Taipei City, TAIWAN verified
- Date published
- 11/24/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- iCareDx PSS-1 RT- PCR Testing System for SARS-CoV-2 using saliva verified
What the source says
ICARE DIAGNOSTICS INTERNATIONALCO, LTD Date Published : 11/24/2021 15 F , Beixin Rd, Sec 3; No 207-3 Xindian Dist , New Taipei City, TAIWAN 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/24/2021 Desc: iCareDx PSS-1 RT- PCR Testing System for SARS-CoV-2 using saliva
— accessdata.fda.gov, retrieved 2026-09-15
The same source also states
ICARE DIAGNOSTICS INTERNATIONALCO, LTD Date Published : 11/24/2021 Zhangshan Rd. , No. 3 Tucheng Dist , New Taipei City, TAIWAN 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/24/2021 Desc: iCareDx PSS-1 RT- PCR Testing System for SARS-CoV-2 using saliva
— 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.