Reference Source

ABNOVA TAIWAN CORPORATION · 89-08 · TAIWAN

For ABNOVA TAIWAN CORPORATION · 89-08 · TAIWAN, 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 TAIWAN; 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

ABNOVA TAIWAN CORPORATION Date Published : 08/31/2021 Neihu District , 9th Fl.; No. 108 Jhouzih St. , Taipei, Taipei TAIWAN 83 Q - - KP Coronavirus antigen detection test system. Date Published: 08/31/2021 Desc: COVID-19 Viral Antigen Rapid Test

accessdata.fda.gov, retrieved 2026-09-15

Source

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

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