Seegene Inc. · 89-08 · KOREA (THE REPUBLIC OF)
For Seegene 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 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 2026-09-16.
- Firm
- Seegene Inc. 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
- KOREA (THE REPUBLIC OF) verified
- Address
- Taewonbilding , 7 F Taewon B/Dsongpa; 91 Ogeum-Ro , Songpa, Seoul KOREA (THE REPUBLIC OF) verified
- Date published
- 12/03/2021 verified
- Product code
- 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices each item verified
- Product
- Allplex SARS-CoV- 2/FluA/FluB/RSV Assay (Cat No. RV10260Y; RV10259X) | Allplex SARS-CoV- 2/Flu/RSV Assay (Cat No. RV10274X; RV10277Y) each item verified
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) 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 12/03/2021 Desc: Allplex SARS-CoV- 2/FluA/FluB/RSV Assay (Cat No. RV10260Y; RV10259X) 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 12/03/2021 Desc: Allplex SARS-CoV- 2/Flu/RSV Assay (Cat No. RV10274X; RV10277Y)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html