Shandong Chengwu Medical Products Factory · 89-08 · CHINA
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
- 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
- Southern End Of Quancheng Road, Chengwu County , Heze, Shandong CHINA verified
- Date published
- 08/19/2021 verified
- 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 each item verified
- 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 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html