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

For Seegene Inc., import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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 Allplex SARS-CoV- 2/FluA/FluB/RSV Assay (Cat No. RV10260Y; RV10259X) | Allplex SARS-CoV- 2/Flu/RSV Assay (Cat No. RV10274X; RV10277Y); product code is 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 12/03/2021; address is Taewonbilding , 7 F Taewon B/Dsongpa; 91 Ogeum-Ro , Songpa, Seoul KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.

What the source says

Seegene Inc. Date Published : 12/03/2021 Taewonbilding , 7 F Taewon B/Dsongpa; 91 Ogeum-Ro , Songpa, Seoul KOREA (THE REPUBLIC OF)

— 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.

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.