# Inno Health Technology, Inc. · 89-08 · TAIWAN — FDA import alert red lists: firms subject to detention without physical examination

For Inno Health Technology, 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 Aculife 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 - - KP Coronavirus antigen detection test system; date published is 03/02/2021; address is 8f-2, No. 61, Section 2 , Kung Yi Road , Taichung, Taiwan, TAIWAN, verified against its source on 2026-09-16.

- **Firm:** Inno Health Technology, 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:** 8f-2, No. 61, Section 2 , Kung Yi Road , Taichung, Taiwan, 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 - - KP Coronavirus antigen detection test system. _(verified: each item appears in the quote below)_
- **Product:** Aculife 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

> Inno Health Technology, Inc. Date Published : 03/02/2021 8f-2, No. 61, Section 2 , Kung Yi Road , Taichung, Taiwan, TAIWAN 83 Q - - KO Reagent, coronavirus serological Date Published: 03/02/2021 Desc: Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method) 83 Q - - KP Coronavirus antigen detection test system. 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/).