ALLBIO SCIENCE INC · 89-08 · TAIWAN
For ALLBIO SCIENCE INC, 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 Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method) | 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 2026-09-30.
- 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
- Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method) | 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
— accessdata.fda.gov, retrieved 2026-09-22
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 - - KO Reagent, coronavirus serological Date Published: 03/02/2021 Desc: Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method) 83 Q - - KO Reagent, coronavirus serological Date Published: 03/02/2021 Desc: COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method)
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html