XIAMEN BAYSEN MEDI · 89-08 · CHINA
For XIAMEN BAYSEN MEDI, 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 Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 Rapid Test Device | Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 Rapid Test Device | SARS-CoV-2 Antigen Rapid Test | COVID-19 Risk Test; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LW COVID-19 test home collection kit devices; date published is 07/27/2021; address is UNIT 401, NO 1 JINZHONG ROAD , HULI DISTRICT , Xiamen, CHINA, verified against its source on 2026-09-30.
- Firm
- XIAMEN BAYSEN MEDI 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
- UNIT 401, NO 1 JINZHONG ROAD , HULI DISTRICT , Xiamen, CHINA verified
- Date published
- 07/27/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LW COVID-19 test home collection kit devices each item verified
- Product
- Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 Rapid Test Device | Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 Rapid Test Device | SARS-CoV-2 Antigen Rapid Test | COVID-19 Risk Test each item verified
What the source says
XIAMEN BAYSEN MEDI Date Published : 07/27/2021 UNIT 401, NO 1 JINZHONG ROAD , HULI DISTRICT , Xiamen, CHINA
— accessdata.fda.gov, retrieved 2026-09-15
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: 07/27/2021 Desc: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 Rapid Test Device 83 Q - - KO Reagent, coronavirus serological Date Published: 07/27/2021 Desc: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 Rapid Test Device 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: SARS-CoV-2 Antigen Rapid Test 83 Q - - LW COVID-19 test home collection kit devices Date Published: 07/27/2021 Desc: COVID-19 Risk Test
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html