Atlas Link (Beijing) Technology Co Ltd · 89-08 · CHINA
For Atlas Link (Beijing) 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 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 2026-09-30.
- 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
What the source says
Atlas Link (Beijing) Technology Co Ltd Date Published : 07/07/2020 Ze Yang Plaza Room 811 , Beijing, 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: 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html