# Lingen Precision Medical Products (Shanghai) Co., Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Lingen Precision Medical Products (Shanghai) Co., Ltd · 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 Viral Transport Media With Guanidine Hydrochloride And Isothiocyanate; models MTM-01; MTM-02; MTM-03; MTM-04; MTM-05 | Viral Transport Media With Guanidine Hydrochloride And Isothiocyanate; models MTM-01; MTM-02; MTM-03; MTM-04; MTM-05; product code is 80 N - - NI Container, Specimen, Non-Sterile | 83 Q - - BD Microbial nucleic acid storage and stabilization device; date published is 08/19/2021; address is No. 59 Yewang Road, Ye , Shanghai, Shanghai CHINA, verified against its source on 2026-09-16.

- **Firm:** Lingen Precision Medical Products (Shanghai) 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:** No. 59 Yewang Road, Ye , Shanghai, Shanghai CHINA _(verified: appears in the quote below)_
- **Date published:** 08/19/2021 _(verified: appears in the quote below)_
- **Product code:** 80 N - - NI Container, Specimen, Non-Sterile | 83 Q - - BD Microbial nucleic acid storage and stabilization device _(verified: each item appears in the quote below)_
- **Product:** Viral Transport Media With Guanidine Hydrochloride And Isothiocyanate; models MTM-01; MTM-02; MTM-03; MTM-04; MTM-05 | Viral Transport Media With Guanidine Hydrochloride And Isothiocyanate; models MTM-01; MTM-02; MTM-03; MTM-04; MTM-05 _(verified: each item appears in the quote below)_

## What the source says

> Lingen Precision Medical Products (Shanghai) Co., Ltd Date Published : 08/19/2021 No. 59 Yewang Road, Ye , Shanghai, Shanghai CHINA 80 N - - NI Container, Specimen, Non-Sterile Date Published: 08/19/2021 Desc: Viral Transport Media With Guanidine Hydrochloride And Isothiocyanate; models MTM-01; MTM-02; MTM-03; MTM-04; MTM-05 83 Q - - BD Microbial nucleic acid storage and stabilization device Date Published: 08/19/2021 Desc: Viral Transport Media With Guanidine Hydrochloride And Isothiocyanate; models MTM-01; MTM-02; MTM-03; MTM-04; MTM-05

## 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/).