# MEDICON COMPANY LIMITED · 89-08 · VIETNAM — FDA import alert red lists: firms subject to detention without physical examination

For MEDICON COMPANY LIMITED · 89-08 · VIETNAM, 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 VIETNAM; product is Trueline COVID-19 IgG/IgM Rapid Test; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 05/04/2021; address is Truong An Industrial Park, An Khanh Ward, Hoai Duc District , No. 17, L12a Trung Yen Urban Area, Yen Hoa Ward, Cau Giay District , Hanoi, thanh pho VIETNAM, verified against its source on 2026-09-16.

- **Firm:** MEDICON COMPANY LIMITED _(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:** VIETNAM _(verified: appears in the quote below)_
- **Address:** Truong An Industrial Park, An Khanh Ward, Hoai Duc District , No. 17, L12a Trung Yen Urban Area, Yen Hoa Ward, Cau Giay District , Hanoi, thanh pho VIETNAM _(verified: appears in the quote below)_
- **Date published:** 05/04/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological _(verified: appears in the quote below)_
- **Product:** Trueline COVID-19 IgG/IgM Rapid Test _(verified: appears in the quote below)_

## What the source says

> MEDICON COMPANY LIMITED Date Published : 05/04/2021 Truong An Industrial Park, An Khanh Ward, Hoai Duc District , No. 17, L12a Trung Yen Urban Area, Yen Hoa Ward, Cau Giay District , Hanoi, thanh pho VIETNAM 83 Q - - KO Reagent, coronavirus serological Date Published: 05/04/2021 Desc: Trueline COVID-19 IgG/IgM 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/).