Reference Source

Lingen Precision Medical Products (Shanghai) Co., Ltd · 89-08 · CHINA

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
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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

accessdata.fda.gov, retrieved 2026-09-15

Source

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