JOYSBIO (TIANJIN) BIOTECHNOLOGY CO., LTD. · 89-08 · CHINA
For JOYSBIO (TIANJIN) BIOTECHNOLOGY CO., LTD., import alert is 89-08; country is CHINA; 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)"; product is COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) | COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) | Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (swab) | EasyRapidNow COVID-19 Nasal Swab Antigen Test | EasyRapidNow COVID-19 Antigen Test/Kit | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | EasyRapidNow COVID-19 Antigen Test/Kit | EasyRapidNow COVID-19 Nasal Swab Antigen Test | Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (swab); 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 2026-09-30.
- Firm
- JOYSBIO (TIANJIN) BIOTECHNOLOGY 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
- 9th Floor , International Joint Academy Of Biotechnology & Medicine , Tianjin, Tianjin CHINA verified
- Date published
- 07/07/2020 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 - - 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. each item verified
- Product
- COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) | COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) | Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (swab) | EasyRapidNow COVID-19 Nasal Swab Antigen Test | EasyRapidNow COVID-19 Antigen Test/Kit | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | EasyRapidNow COVID-19 Antigen Test/Kit | EasyRapidNow COVID-19 Nasal Swab Antigen Test | Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (swab) each item verified
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
— accessdata.fda.gov, retrieved 2026-09-22
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
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: 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: 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 - - KO Reagent, coronavirus serological Date Published: 09/30/2021 Desc: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 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) 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: 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: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (swab)
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html