MIRXES PTE LTD · 89-08 · SINGAPORE

For MIRXES PTE LTD · 89-08 · SINGAPORE, 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 SINGAPORE; product is MiRXES Fortitude Kit 3.0 COVID-19 RT-PCR Test | MiRXES Fortitude Kit 3.0 COVID-19 RT-PCR Test | MiRXES Fortitude SARS-CoV-2 & FluA/B Test; product code is 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 09/30/2021; address is 2 Tukang Innovation Grove , #09-02 Jtc Medtech Hub , Singapore, SINGAPORE, verified against its source on 2026-09-16.

What the source says

MIRXES PTE LTD Date Published : 09/30/2021 2 Tukang Innovation Grove , #09-02 Jtc Medtech Hub , Singapore, SINGAPORE 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. Date Published: 06/13/2022 Desc: MiRXES Fortitude Kit 3.0 COVID-19 RT-PCR Test 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/13/2022 Desc: MiRXES Fortitude Kit 3.0 COVID-19 RT-PCR Test 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 09/30/2021 Desc: MiRXES Fortitude SARS-CoV-2 & FluA/B Test

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

Source

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

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.