Hangzhou Clongene Biotech Co., Ltd. · 89-08 · CHINA
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
- 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
- Address
- No. 1 Yuchang Road , Yuhang , Hangzhou, Zhejiang CHINA verified
- Date published
- 09/02/2020 verified
- 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. each item verified
- 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 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html