TCM BIOSCIENCES · 89-08 · KOREA (THE REPUBLIC OF)
For TCM BIOSCIENCES, 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 TCM-Q Corona III Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 06/08/2022; address is 3rd Fl, Bldg3, 15 Pangy , Gyeonggi-Do, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- TCM BIOSCIENCES 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
- 3rd Fl, Bldg3, 15 Pangy , Gyeonggi-Do, KOREA (THE REPUBLIC OF) verified
- Date published
- 06/08/2022 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- TCM-Q Corona III Kit verified
What the source says
TCM BIOSCIENCES Date Published : 06/08/2022 3rd Fl, Bldg3, 15 Pangy , Gyeonggi-Do, 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.
Product code and Product
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/08/2022 Desc: TCM-Q Corona III Kit
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html