JOYSBIO (TIANJIN) BIOTECHNOLOGY CO., LTD. · 89-08 · CHINA

For JOYSBIO (TIANJIN) BIOTECHNOLOGY 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 COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) | Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (swab) | COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | EasyRapidNow COVID-19 Nasal Swab Antigen Test | EasyRapidNow COVID-19 Antigen Test/Kit | Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (swab) | EasyRapidNow COVID-19 Nasal Swab Antigen Test | EasyRapidNow COVID-19 Antigen Test/Kit | COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); 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 - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 07/07/2020; address is 9th Floor , International Joint Academy Of Biotechnology & Medicine , Tianjin, Tianjin CHINA, verified against its source on 2026-09-16.

What the source says

JOYSBIO (TIANJIN) BIOTECHNOLOGY CO., LTD. Date Published : 07/07/2020 9th Floor , International Joint Academy Of Biotechnology & Medicine , Tianjin, Tianjin CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/07/2020 Desc: COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) 83 Q - - KO Reagent, coronavirus serological Date Published: 09/30/2021 Desc: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (swab) 83 Q - - KO Reagent, coronavirus serological Date Published: 07/07/2020 Desc: COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) 83 Q - - KO Reagent, coronavirus serological Date Published: 09/30/2021 Desc: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 83 Q - - KO Reagent, coronavirus serological Date Published: 09/30/2021 Desc: EasyRapidNow COVID-19 Nasal Swab Antigen Test 83 Q - - KO Reagent, coronavirus serological Date Published: 09/30/2021 Desc: EasyRapidNow COVID-19 Antigen Test/Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 09/30/2021 Desc: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (swab) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 09/30/2021 Desc: EasyRapidNow COVID-19 Nasal Swab Antigen Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 09/30/2021 Desc: EasyRapidNow COVID-19 Antigen Test/Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/07/2020 Desc: COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 09/30/2021 Desc: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)

— accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.