# Innovita (Tangshan) Biological Technology Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Innovita (Tangshan) Biological Technology Co., Ltd. · 89-08 · CHINA, 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 CHINA; product is Scanwell SARS-CoV-2 IgM & IgG Test System | Innovita 2019-nCoV Ag Test (Latex Chromatography Assay); product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 06/22/2021; address is No.699 Juxin Street,High-tech Industrial Development Zone , Qian'An, Hebei CHINA, verified against its source on 2026-09-16.

- **Firm:** Innovita (Tangshan) Biological Technology Co., Ltd. _(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:** CHINA _(verified: appears in the quote below)_
- **Address:** No.699 Juxin Street,High-tech Industrial Development Zone , Qian'An, Hebei CHINA _(verified: appears in the quote below)_
- **Date published:** 06/22/2021 _(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:** Scanwell SARS-CoV-2 IgM & IgG Test System | Innovita 2019-nCoV Ag Test (Latex Chromatography Assay) _(verified: each item appears in the quote below)_

## What the source says

> Innovita (Tangshan) Biological Technology Co., Ltd. Date Published : 06/22/2021 No.699 Juxin Street,High-tech Industrial Development Zone , Qian'An, Hebei CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 08/30/2021 Desc: Scanwell SARS-CoV-2 IgM & IgG Test System 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2021 Desc: Innovita 2019-nCoV Ag Test (Latex Chromatography Assay)

## 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/).