ABNOVA TAIWAN CORPORATION · 89-08 · TAIWAN
For ABNOVA TAIWAN 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 COVID-19 Viral Antigen Rapid Test; product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 08/31/2021; address is Neihu District , 9th Fl.; No. 108 Jhouzih St. , Taipei, Taipei TAIWAN, verified against its source on 2026-09-30.
- Firm
- ABNOVA TAIWAN 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
- Neihu District , 9th Fl.; No. 108 Jhouzih St. , Taipei, Taipei TAIWAN verified
- Date published
- 08/31/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. verified
- Product
- COVID-19 Viral Antigen Rapid Test verified
What the source says
ABNOVA TAIWAN CORPORATION Date Published : 08/31/2021 Neihu District , 9th Fl.; No. 108 Jhouzih St. , Taipei, Taipei 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 - - KP Coronavirus antigen detection test system. Date Published: 08/31/2021 Desc: COVID-19 Viral Antigen Rapid Test
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html