Taigen Bioscience Corporation · 89-08 · TAIWAN
For Taigen Bioscience Corporation, import alert is 89-08; country is TAIWAN; 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 LabTurbo AIO COVID-19 RNA Testing Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 06/08/2022; address is No 150, Section 4 , 3 F.; Chengde Road , Shilin District, Taipei - District TAIWAN, verified against its source on 2026-09-30.
- Firm
- Taigen Bioscience Corporation 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
- TAIWAN verified
- Address
- No 150, Section 4 , 3 F.; Chengde Road , Shilin District, Taipei - District TAIWAN verified
- Date published
- 06/08/2022 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- LabTurbo AIO COVID-19 RNA Testing Kit verified
What the source says
Taigen Bioscience Corporation Date Published : 06/08/2022 No 150, Section 4 , 3 F.; Chengde Road , Shilin District, Taipei - District TAIWAN
— 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: LabTurbo AIO COVID-19 RNA Testing Kit
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html