# Shandong Chengwu Medical Products Factory · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Shandong Chengwu Medical Products Factory · 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 media Viral transport tube | Disposable Virus Specimen Collection Tube (Preservation solution; Viral Transport Media) Type; CW-01; CW-02; CW-03; CW-04 | Disposable Virus Specimen Collection Tube (Preservation solution; Viral Transport Media) Type; CW-01; CW-02; CW-03; CW-04; product code is 80 K - - XG Applicator, Absorbent Tipped, Sterile | 83 J - - SG Culture Media, Non-Selective And Non-Differential | 83 J - - SM Culture Media, Non-Propagating Transport | 83 Q - - MC Transport medium, notified per the VTM guidance; date published is 08/19/2021; address is Southern End Of Quancheng Road, Chengwu County , Heze, Shandong CHINA, verified against its source on 2026-09-16.

- **Firm:** Shandong Chengwu Medical Products Factory _(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:** Southern End Of Quancheng Road, Chengwu County , Heze, Shandong CHINA _(verified: appears in the quote below)_
- **Date published:** 08/19/2021 _(verified: appears in the quote below)_
- **Product code:** 80 K - - XG Applicator, Absorbent Tipped, Sterile | 83 J - - SG Culture Media, Non-Selective And Non-Differential | 83 J - - SM Culture Media, Non-Propagating Transport | 83 Q - - MC Transport medium, notified per the VTM guidance _(verified: each item appears in the quote below)_
- **Product:** Disposable Virus Specimen Collection Tube | Viral transport media Viral transport tube | Disposable Virus Specimen Collection Tube (Preservation solution; Viral Transport Media) Type; CW-01; CW-02; CW-03; CW-04 | Disposable Virus Specimen Collection Tube (Preservation solution; Viral Transport Media) Type; CW-01; CW-02; CW-03; CW-04 _(verified: each item appears in the quote below)_

## What the source says

> Shandong Chengwu Medical Products Factory Date Published : 08/19/2021 Southern End Of Quancheng Road, Chengwu County , Heze, Shandong CHINA 80 K - - XG Applicator, Absorbent Tipped, Sterile Date Published: 10/06/2021 Desc: Disposable Virus Specimen Collection Tube 83 J - - SG Culture Media, Non-Selective And Non-Differential Date Published: 10/06/2021 Desc: Viral transport media Viral transport tube 83 J - - SM Culture Media, Non-Propagating Transport Date Published: 08/19/2021 Desc: Disposable Virus Specimen Collection Tube (Preservation solution; Viral Transport Media) Type; CW-01; CW-02; CW-03; CW-04 83 Q - - MC Transport medium, notified per the VTM guidance Date Published: 08/19/2021 Desc: Disposable Virus Specimen Collection Tube (Preservation solution; Viral Transport Media) Type; CW-01; CW-02; CW-03; CW-04

## 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/).