Reference Source

Shenzhen Reagent Technology Co Ltd · 89-08 · CHINA

For Shenzhen Reagent Technology 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 COVID-19 Real-Time Fluorescence PCR Detection Kit (lyophilized); product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 12/03/2021; address is Hangcheng Wisdom Science Park R7777 , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-30.

Firm
Shenzhen Reagent Technology 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
Hangcheng Wisdom Science Park R7777 , Shenzhen, Guangdong CHINA verified
Date published
12/03/2021 verified
Product code
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
Product
COVID-19 Real-Time Fluorescence PCR Detection Kit (lyophilized) verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Shenzhen Reagent Technology Co Ltd Date Published : 12/03/2021 Hangcheng Wisdom Science Park R7777 , Shenzhen, Guangdong 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

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 12/03/2021 Desc: COVID-19 Real-Time Fluorescence PCR Detection Kit (lyophilized)

— 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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