ALLBIO SCIENCE INC · 89-08 · TAIWAN
For ALLBIO SCIENCE INC · 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 COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method) | Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method); product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 03/02/2021; address is 5F., No. 357, Sec. 3 , Xifeng Road, Northern District , Taichung, TAIWAN, verified against its source on 2026-09-16.
- Firm
- ALLBIO SCIENCE 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
- TAIWAN verified
- Address
- 5F., No. 357, Sec. 3 , Xifeng Road, Northern District , Taichung, TAIWAN verified
- Date published
- 03/02/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method) | Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method) each item verified
What the source says
ALLBIO SCIENCE INC Date Published : 03/02/2021 5F., No. 357, Sec. 3 , Xifeng Road, Northern District , Taichung, TAIWAN 83 Q - - KO Reagent, coronavirus serological Date Published: 03/02/2021 Desc: COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method) 83 Q - - KO Reagent, coronavirus serological Date Published: 03/02/2021 Desc: Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.