ICARE DIAGNOSTICS INTERNATIONALCO, LTD · 89-08 · TAIWAN

For ICARE DIAGNOSTICS INTERNATIONALCO, LTD, import alert is 89-08; country is TAIWAN; 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 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 listed twice: 15 F , Beixin Rd, Sec 3; No 207-3 Xindian Dist , New Taipei City, TAIWAN and Zhangshan Rd. , No. 3 Tucheng Dist , New Taipei City, TAIWAN, verified against its source on 2026-09-30.

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

— 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.

— all from 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

— accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.