# CHANGSHA RENJI MEDICAL EQUIPMENT CO., LTD. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: 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:** Building B8, No. 18 Xiangtai Road, Changsha E Center, Liuyang Jingkai District , Changsha, CHINA _(verified: appears in the quote below)_
- **Date published:** 10/07/2026 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in its own passage below)_
- **Product:** Disposable Virus Specimen Collection Tubes | Disposable Virus Specimen Collection Tubes | Disposable Virus Specimen Collection Tubes _(verified: each item appears in its own passage below)_

## 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

## Where each value comes from

This source states these in separate places, so each value is shown with the passage that states it.

### Product code

> 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

### 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-10-08. Review by: 2026-12-07.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).