Haimen Shengbang Laboratory Equipment Co. Ltd. · 89-08 · CHINA
For Haimen Shengbang Laboratory Equipment 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 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 2026-09-30.
- 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
— 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.
Product code and Product
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html