MIRXES PTE LTD · 89-08 · SINGAPORE

For MIRXES PTE LTD, import alert is 89-08; country is SINGAPORE; 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 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 2026-09-30.

What the source says

MIRXES PTE LTD Date Published : 09/30/2021 2 Tukang Innovation Grove , #09-02 Jtc Medtech Hub , Singapore, SINGAPORE

— 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

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.