Biobase Biodustry (Shandong)Co., Ltd · 89-08 · CHINA

For Biobase Biodustry (Shandong)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 Disposable Virus Sampling Tube Kit- not inactivated | VTM Swab Sample Collection Tube Disposable Sampling Tube Kit (Shandong) -not inactivated | Disposable Virus Sampling Tube Kit- inactivated | VTM Swab Sample Collection Tube Disposable Sampling Tube Kit (Shandong) -Inactive | SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold) | 2019-nCoV RT-qPCR Detection Kit (Colloidal Gold) | Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR) | SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold) | SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold) | SARS-CoV-2 Antigen Test Kit (Colloidal Gold); product code is 83 J - - SM Culture Media, Non-Propagating Transport | 83 J - - SM Culture Media, Non-Propagating Transport | 83 Q - - BD Microbial nucleic acid storage and stabilization device | 83 Q - - BD Microbial nucleic acid storage and stabilization device | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 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 - - KP Coronavirus antigen detection test system; date published is 06/23/2020; address is Biobase Biological Industrial Park , Mingshui; Economic Development Zone , Jinan, Shandong CHINA, verified against its source on 2026-09-30.

What the source says

Biobase Biodustry (Shandong)Co., Ltd Date Published : 06/23/2020 Biobase Biological Industrial Park , Mingshui; Economic Development Zone , Jinan, Shandong 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.

— all from accessdata.fda.gov, retrieved 2026-09-22

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.