Biobase Biodustry (Shandong)Co., Ltd · 89-08 · CHINA
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
- 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
- Biobase Biological Industrial Park , Mingshui; Economic Development Zone , Jinan, Shandong CHINA verified
- Date published
- 06/23/2020 verified
- 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. each item verified
- 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) each item verified
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)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html