# Hangzhou Clongene Biotech Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Hangzhou Clongene Biotech 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 Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette | CLUNGENE COVID-19 IgG/IgM Rapid Test Kit | CLUNGENE SARSCOV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette | Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette | Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 09/02/2020; address is No. 1 Yuchang Road , Yuhang , Hangzhou, Zhejiang CHINA, verified against its source on 2026-09-16.

- **Firm:** Hangzhou Clongene Biotech 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. 1 Yuchang Road , Yuhang , Hangzhou, Zhejiang CHINA _(verified: appears in the quote below)_
- **Date published:** 09/02/2020 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. _(verified: each item appears in the quote below)_
- **Product:** Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette | CLUNGENE COVID-19 IgG/IgM Rapid Test Kit | CLUNGENE SARSCOV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette | Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette | Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette _(verified: each item appears in the quote below)_

## What the source says

> Hangzhou Clongene Biotech Co., Ltd. Date Published : 09/02/2020 No. 1 Yuchang Road , Yuhang , Hangzhou, Zhejiang CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/02/2020 Desc: Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette 83 Q - - KO Reagent, coronavirus serological Date Published: 04/19/2022 Desc: CLUNGENE COVID-19 IgG/IgM Rapid Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 04/19/2022 Desc: CLUNGENE SARSCOV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette 83 Q - - KO Reagent, coronavirus serological Date Published: 09/02/2020 Desc: Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette 83 Q - - KP Coronavirus antigen detection test system. Date Published: 09/02/2020 Desc: Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette

## The same source also states

> Hangzhou Clongene Biotech Co., Ltd. Date Published : 06/23/2020 No. 1 Yuchang Road , Yuhang , Hangzhou, Zhejiang CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/23/2020 Desc: COMBRA COVID-19 IgM/IgG Rapid Test Cassette 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/02/2020 Desc: Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette 83 Q - - KO Reagent, coronavirus serological Date Published: 06/23/2020 Desc: COMBRA COVID-19 IgM/IgG Rapid Test Cassette 83 Q - - KO Reagent, coronavirus serological Date Published: 09/02/2020 Desc: Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/23/2020 Desc: COMBRA COVID-19 IgM/IgG Rapid Test Cassette 83 Q - - KP Coronavirus antigen detection test system. Date Published: 09/02/2020 Desc: Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette

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

## 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/).