Xiamen Wiz Biotech Co., Ltd. · 89-08 · CHINA

For Xiamen Wiz Biotech 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 DIAGNOSTIC KIT (COLLOIDAL GOLD) FOR IGG/IGM ANTIBODY TO SARS-COV-2 | DIAGNOSTIC KIT (COLLOIDAL GOLD) FOR IGG/IGM ANTIBODY TO SARS-COV-2 | DIAGNOSTIC KIT (COLLOIDAL GOLD) FOR IGG/IGM ANTIBODY TO SARS-COV-2 | DIAGNOSTIC KIT (COLLOIDAL GOLD) FOR IGG/IGM ANTIBODY TO SARS-COV-2; 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 - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 10/22/2020; address is Bio-Medical Workshop, Floor 3-4, Bldg 16 , 2030 Wengjiao West Road; Haicang , Xiamen, Fujian CHINA, verified against its source on 2026-09-30.

What the source says

Xiamen Wiz Biotech Co., Ltd. Date Published : 10/22/2020 Bio-Medical Workshop, Floor 3-4, Bldg 16 , 2030 Wengjiao West Road; Haicang , Xiamen, Fujian 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.

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

Source

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

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.