# RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD. · 89-08 · MALAYSIA — FDA import alert red lists: firms subject to detention without physical examination

For RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD. · 89-08 · MALAYSIA, 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 MALAYSIA; product is (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test | (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test | (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test | (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 10/21/2020; address is Revongen Corporation Center, Level 17 , Top Glove Tower , Shah Alam, Selangor MALAYSIA, verified against its source on 2026-09-16.

- **Firm:** RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD. _(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:** MALAYSIA _(verified: appears in the quote below)_
- **Address:** Revongen Corporation Center, Level 17 , Top Glove Tower , Shah Alam, Selangor MALAYSIA _(verified: appears in the quote below)_
- **Date published:** 10/21/2020 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices _(verified: each item appears in the quote below)_
- **Product:** (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test | (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test | (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test | (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test _(verified: each item appears in the quote below)_

## What the source says

> RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD. Date Published : 10/21/2020 Revongen Corporation Center, Level 17 , Top Glove Tower , Shah Alam, Selangor MALAYSIA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/21/2020 Desc: (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test 83 Q - - KO Reagent, coronavirus serological Date Published: 10/21/2020 Desc: (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/21/2020 Desc: (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/21/2020 Desc: (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody 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/).