RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD. · 89-08 · MALAYSIA
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
- 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
- Address
- Revongen Corporation Center, Level 17 , Top Glove Tower , Shah Alam, Selangor MALAYSIA verified
- Date published
- 10/21/2020 verified
- 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 each item verified
- 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 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html