Cellex Inc., Suzhou · 89-08 · CHINA

For Cellex Inc., Suzhou · 89-08 · CHINA, 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 CHINA; product is qSARS-CoV-2 IgG/IgM Rapid Test | Exa SARS- CoV-2 Rapid Antigen Test | Artemis System COVID-19 Antigen Rapid Test | Artemis Rapid Antigen Test Kit | qSARS-CoV-2 Antigen Rapid Test; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 06/22/2021; address is Bldg 16 , Suzhou, Jiangsu CHINA, verified against its source on 2026-09-16.

What the source says

Cellex Inc., Suzhou Date Published : 06/22/2021 Bldg 16 , Suzhou, Jiangsu CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 01/10/2022 Desc: qSARS-CoV-2 IgG/IgM Rapid Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/04/2022 Desc: Exa SARS- CoV-2 Rapid Antigen Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2021 Desc: Artemis System COVID-19 Antigen Rapid Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2021 Desc: Artemis Rapid Antigen Test Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2021 Desc: qSARS-CoV-2 Antigen Rapid 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.