Haimen Shengbang Laboratory Equipment Co. Ltd. · 89-08 · CHINA
For Haimen Shengbang Laboratory Equipment 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 Specimen Collection Tube | Viral Transport Tube; Type HX-K59; HX-K60; HX-K61 | Viral Transport Media; Type HX-K59; HX-K60; HX-K61 | Viral Transport Tube; Type HX-K59; HX-K60; HX-K61 | Viral Transport Media; Type HX-K59; HX-K60; HX-K61 | Viral Transport Tube; Type HX-K59; HX-K60; HX-K61 | Virus Collection Tube Kit; product code is 80 N - - NI Container, Specimen, Non-Sterile | 83 J - - SG Culture Media, Non-Selective And Non-Differential | 83 J - - SM Culture Media, Non-Propagating Transport | 83 J - - SM Culture Media, Non-Propagating Transport | 83 Q - - MC Transport medium, notified per the VTM guidance | 83 Q - - MC Transport medium, notified per the VTM guidance | 88 K - - JG Tube, Tissue Culture; date published is 08/19/2021; address is D, Sanhe , No. 50 Xue Qian Road; Sanhezhen Haimen , Nantong, Jiangsu CHINA, verified against its source on 2026-09-16.
- Firm
- Haimen Shengbang Laboratory Equipment 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
- D, Sanhe , No. 50 Xue Qian Road; Sanhezhen Haimen , Nantong, Jiangsu CHINA verified
- Date published
- 08/19/2021 verified
- Product code
- 80 N - - NI Container, Specimen, Non-Sterile | 83 J - - SG Culture Media, Non-Selective And Non-Differential | 83 J - - SM Culture Media, Non-Propagating Transport | 83 J - - SM Culture Media, Non-Propagating Transport | 83 Q - - MC Transport medium, notified per the VTM guidance | 83 Q - - MC Transport medium, notified per the VTM guidance | 88 K - - JG Tube, Tissue Culture each item verified
- Product
- Disposable Virus Specimen Collection Tube | Viral Transport Tube; Type HX-K59; HX-K60; HX-K61 | Viral Transport Media; Type HX-K59; HX-K60; HX-K61 | Viral Transport Tube; Type HX-K59; HX-K60; HX-K61 | Viral Transport Media; Type HX-K59; HX-K60; HX-K61 | Viral Transport Tube; Type HX-K59; HX-K60; HX-K61 | Virus Collection Tube Kit each item verified
What the source says
Haimen Shengbang Laboratory Equipment Co. Ltd. Date Published : 08/19/2021 D, Sanhe , No. 50 Xue Qian Road; Sanhezhen Haimen , Nantong, Jiangsu CHINA 80 N - - NI Container, Specimen, Non-Sterile Date Published: 10/06/2021 Desc: Disposable Virus Specimen Collection Tube 83 J - - SG Culture Media, Non-Selective And Non-Differential Date Published: 08/04/2022 Desc: Viral Transport Tube; Type HX-K59; HX-K60; HX-K61 83 J - - SM Culture Media, Non-Propagating Transport Date Published: 08/19/2021 Desc: Viral Transport Media; Type HX-K59; HX-K60; HX-K61 83 J - - SM Culture Media, Non-Propagating Transport Date Published: 08/19/2021 Desc: Viral Transport Tube; Type HX-K59; HX-K60; HX-K61 83 Q - - MC Transport medium, notified per the VTM guidance Date Published: 08/19/2021 Desc: Viral Transport Media; Type HX-K59; HX-K60; HX-K61 83 Q - - MC Transport medium, notified per the VTM guidance Date Published: 08/19/2021 Desc: Viral Transport Tube; Type HX-K59; HX-K60; HX-K61 88 K - - JG Tube, Tissue Culture Date Published: 08/04/2022 Desc: Virus Collection Tube Kit
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html