CHANGSHA RENJI MEDICAL EQUIPMENT CO., LTD. · 89-08 · CHINA
For CHANGSHA RENJI MEDICAL 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 Tubes | Disposable Virus Specimen Collection Tubes | Disposable Virus Specimen Collection Tubes; product code is 83 J - - SM Culture Media, Non-Propagating Transport | 83 L - - IO Device, Specimen Collection | 83 Q - - MC Transport medium, notified per the VTM guidance; date published is 10/07/2026; address is Building B8, No. 18 Xiangtai Road, Changsha E Center, Liuyang Jingkai District , Changsha, CHINA, verified against its source on 2026-10-08.
- Firm
- CHANGSHA RENJI MEDICAL 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
- Building B8, No. 18 Xiangtai Road, Changsha E Center, Liuyang Jingkai District , Changsha, CHINA verified
- Date published
- 10/07/2026 verified
- Product code
- 83 J - - SM Culture Media, Non-Propagating Transport | 83 L - - IO Device, Specimen Collection | 83 Q - - MC Transport medium, notified per the VTM guidance each item verified
- Product
- Disposable Virus Specimen Collection Tubes | Disposable Virus Specimen Collection Tubes | Disposable Virus Specimen Collection Tubes each item verified
What the source says
CHANGSHA RENJI MEDICAL EQUIPMENT CO., LTD. Date Published : 10/07/2026 Building B8, No. 18 Xiangtai Road, Changsha E Center, Liuyang Jingkai District , Changsha, CHINA
— accessdata.fda.gov, retrieved 2026-10-08
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
83 J - - SM Culture Media, Non-Propagating Transport Date Published: 10/07/2026 Desc: Disposable Virus Specimen Collection Tubes 83 L - - IO Device, Specimen Collection Date Published: 10/07/2026 Desc: Disposable Virus Specimen Collection Tubes 83 Q - - MC Transport medium, notified per the VTM guidance Date Published: 10/07/2026 Desc: Disposable Virus Specimen Collection Tubes
— all from accessdata.fda.gov, retrieved 2026-10-08
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html