# MIRXES PTE LTD · 89-08 · SINGAPORE — FDA import alert red lists: firms subject to detention without physical examination

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.

- **Firm:** MIRXES PTE 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:** SINGAPORE _(verified: appears in the quote below)_
- **Address:** 2 Tukang Innovation Grove , #09-02 Jtc Medtech Hub , Singapore, SINGAPORE _(verified: appears in the quote below)_
- **Date published:** 09/30/2021 _(verified: appears in the quote below)_
- **Product code:** 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 _(verified: each item appears in the quote below)_
- **Product:** 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 _(verified: each item appears in the quote below)_

## 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

## 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/).