# ALLBIO SCIENCE INC · 89-08 · TAIWAN — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 5F., No. 357, Sec. 3 , Xifeng Road, Northern District , Taichung, TAIWAN _(verified: appears in the quote below)_
- **Date published:** 03/02/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological _(verified: each item appears in the quote below)_
- **Product:** COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method) | Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method) _(verified: each item appears in the quote below)_

## 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)

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).