# ICARE DIAGNOSTICS INTERNATIONALCO, LTD · 89-08 · TAIWAN — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 15 F , Beixin Rd, Sec 3; No 207-3 Xindian Dist , New Taipei City, TAIWAN _(verified: appears in the quote below)_
- **Date published:** 11/24/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid _(verified: appears in the quote below)_
- **Product:** iCareDx PSS-1 RT- PCR Testing System for SARS-CoV-2 using saliva _(verified: appears in the quote below)_

## 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

## 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

Source: https://www.accessdata.fda.gov/cms_ia/importalert_244.html

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).