Reference Source

Shenzhen Reagent Technology Co Ltd · 89-08 · CHINA

For Shenzhen Reagent Technology 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 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 2026-09-16.

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

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

Source

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