MEDICON COMPANY LIMITED · 89-08 · VIETNAM
For MEDICON COMPANY LIMITED, import alert is 89-08; country is VIETNAM; 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)"; 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 2026-09-30.
- Firm
- MEDICON COMPANY LIMITED 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
- VIETNAM verified
- 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
- Date published
- 05/04/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- Trueline COVID-19 IgG/IgM Rapid Test verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
83 Q - - KO Reagent, coronavirus serological Date Published: 05/04/2021 Desc: Trueline COVID-19 IgG/IgM Rapid Test
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html