Bionote, Inc. · 89-08 · KOREA (THE REPUBLIC OF)

For Bionote, Inc. · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); product is NowCheck COVID-19 Ag Test | NowCheck COVID-19 Ag Test | NowCheck COVID-19 Ag Test | NowCheck COVID-19 IgM/IgG Test | NowCheck COVID-19 Ag Test; product code is 83 O - - TG Non-sars coronavirus multiplex nucleic acid assay | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 03/02/2021; address is 22, Samsung 1-Ro 4-Gil, Hwaseong-Si, , Gyeonggi-do, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

What the source says

Bionote, Inc. Date Published : 03/02/2021 22, Samsung 1-Ro 4-Gil, Hwaseong-Si, , Gyeonggi-do, KOREA (THE REPUBLIC OF) 83 O - - TG Non-sars coronavirus multiplex nucleic acid assay Date Published: 03/02/2021 Desc: NowCheck COVID-19 Ag Test 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 03/02/2021 Desc: NowCheck COVID-19 Ag Test 83 Q - - KO Reagent, coronavirus serological Date Published: 03/02/2021 Desc: NowCheck COVID-19 Ag Test 83 Q - - KO Reagent, coronavirus serological Date Published: 08/25/2021 Desc: NowCheck COVID-19 IgM/IgG Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 03/02/2021 Desc: NowCheck COVID-19 Ag 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.