SURE BIO TECH · 89-08 · CHINA
For SURE BIO TECH · 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 API Covid-Rapid IgM/IgG Antibody Test Kit | Covid-Rapid SARS-CoV-2 IgM/IgG AB (WB/S/P) | API Covid-Rapid IgM/IgG Antibody Test Kit | API Pharma Covid-Rapid IgM/IgG Antibody Test | API Covid-Rapid IgM/IgG Antibody Test Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 07/16/2020; address is No.369 Hedong Road, Hi-Tech Industrial Development , Qingdao City Shandong, Shandong CHINA, verified against its source on 2026-09-16.
- Firm
- SURE BIO TECH 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.369 Hedong Road, Hi-Tech Industrial Development , Qingdao City Shandong, Shandong CHINA verified
- Date published
- 07/16/2020 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- API Covid-Rapid IgM/IgG Antibody Test Kit | Covid-Rapid SARS-CoV-2 IgM/IgG AB (WB/S/P) | API Covid-Rapid IgM/IgG Antibody Test Kit | API Pharma Covid-Rapid IgM/IgG Antibody Test | API Covid-Rapid IgM/IgG Antibody Test Kit each item verified
What the source says
SURE BIO TECH Date Published : 07/16/2020 No.369 Hedong Road, Hi-Tech Industrial Development , Qingdao City Shandong, Shandong CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/16/2020 Desc: API Covid-Rapid IgM/IgG Antibody Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 03/23/2021 Desc: Covid-Rapid SARS-CoV-2 IgM/IgG AB (WB/S/P) 83 Q - - KO Reagent, coronavirus serological Date Published: 07/16/2020 Desc: API Covid-Rapid IgM/IgG Antibody Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 03/23/2021 Desc: API Pharma Covid-Rapid IgM/IgG Antibody Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/16/2020 Desc: API Covid-Rapid IgM/IgG Antibody Test Kit
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html