# Biobase Biodustry (Shandong)Co., Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Biobase Biodustry (Shandong)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 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 | 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 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 2026-09-16.

- **Firm:** Biobase Biodustry (Shandong)Co., Ltd _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Biobase Biological Industrial Park , Mingshui; Economic Development Zone , Jinan, Shandong CHINA _(verified: appears in the quote below)_
- **Date published:** 06/23/2020 _(verified: appears in the quote below)_
- **Product code:** 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. _(verified: each item appears in the quote below)_
- **Product:** 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 | 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 IgM/IgG Antibody Test Kit (Colloidal Gold) | SARS-CoV-2 Antigen Test Kit (Colloidal Gold) _(verified: each item appears in the quote below)_

## 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 83 J - - SM Culture Media, Non-Propagating Transport Date Published: 04/01/2022 Desc: Disposable Virus Sampling Tube Kit- not inactivated 83 J - - SM Culture Media, Non-Propagating Transport Date Published: 04/01/2022 Desc: VTM Swab Sample Collection Tube Disposable Sampling Tube Kit (Shandong) -not inactivated 83 Q - - BD Microbial nucleic acid storage and stabilization device Date Published: 04/01/2022 Desc: Disposable Virus Sampling Tube Kit- inactivated 83 Q - - BD Microbial nucleic acid storage and stabilization device Date Published: 04/01/2022 Desc: VTM Swab Sample Collection Tube Disposable Sampling Tube Kit (Shandong) -Inactive 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 04/01/2022 Desc: 2019-nCoV RT-qPCR Detection Kit (Colloidal Gold) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 04/01/2022 Desc: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/23/2020 Desc: SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold) 83 Q - - KO Reagent, coronavirus serological Date Published: 06/23/2020 Desc: SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/23/2020 Desc: SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/01/2022 Desc: SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).