Reference Source

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
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

— 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

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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