Lingen Precision Medical Products (Shanghai) Co., Ltd · 89-08 · CHINA
For Lingen Precision Medical Products (Shanghai) 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 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 2026-09-30.
- Firm
- Lingen Precision Medical Products (Shanghai) 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
- No. 59 Yewang Road, Ye , Shanghai, Shanghai CHINA verified
- Date published
- 08/19/2021 verified
- Product code
- 80 N - - NI Container, Specimen, Non-Sterile | 83 Q - - BD Microbial nucleic acid storage and stabilization device each item verified
- 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 each item verified
What the source says
Lingen Precision Medical Products (Shanghai) Co., Ltd Date Published : 08/19/2021 No. 59 Yewang Road, Ye , Shanghai, Shanghai CHINA
— accessdata.fda.gov, retrieved 2026-09-15
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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html