Reference Source

MEDICON COMPANY LIMITED · 89-08 · VIETNAM

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
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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

accessdata.fda.gov, retrieved 2026-09-15

Source

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