# Cellex Inc., Suzhou · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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.

- **Firm:** Cellex Inc., Suzhou _(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:** CHINA _(verified: appears in the quote below)_
- **Address:** Bldg 16 , Suzhou, Jiangsu CHINA _(verified: appears in the quote below)_
- **Date published:** 06/22/2021 _(verified: appears in the quote below)_
- **Product code:** 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. _(verified: each item appears in the quote below)_
- **Product:** 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 _(verified: each item appears in the quote below)_

## 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

## 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/).