Reference Source

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.