Reference Source

Atlas Link (Beijing) Technology Co Ltd · 89-08 · CHINA

For Atlas Link (Beijing) 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 NOVA COVID-19 IgG/IgM Antibody Rapid Test | NOVA COVID-19 IgG/IgM Antibody Rapid Test | NOVA COVID-19 IgG/IgM Antibody Rapid Test; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 07/07/2020; address is Ze Yang Plaza Room 811 , Beijing, CHINA, verified against its source on 2026-09-16.

Firm
Atlas Link (Beijing) 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
Ze Yang Plaza Room 811 , Beijing, CHINA verified
Date published
07/07/2020 verified
Product code
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. each item verified
Product
NOVA COVID-19 IgG/IgM Antibody Rapid Test | NOVA COVID-19 IgG/IgM Antibody Rapid Test | NOVA COVID-19 IgG/IgM Antibody Rapid Test 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

Atlas Link (Beijing) Technology Co Ltd Date Published : 07/07/2020 Ze Yang Plaza Room 811 , Beijing, CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/07/2020 Desc: NOVA COVID-19 IgG/IgM Antibody Rapid Test 83 Q - - KO Reagent, coronavirus serological Date Published: 07/07/2020 Desc: NOVA COVID-19 IgG/IgM Antibody Rapid Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/07/2020 Desc: NOVA COVID-19 IgG/IgM Antibody Rapid Test

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

Source

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