BESTNOVO MEDICAL TECHNOLOGY · 89-08 · CHINA

For BESTNOVO MEDICAL TECHNOLOGY · 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 BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit | BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit | BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit; 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 06/23/2020; address is Fl 4 , No. 73 Bldg G57 , Taizhou, CHINA, verified against its source on 2026-09-16.

Firm: BESTNOVO MEDICAL TECHNOLOGY 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: Fl 4 , No. 73 Bldg G57 , Taizhou, CHINA verified
Date published: 06/23/2020 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: BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit | BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit | BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit each item verified

Sourceaccessdata.fda.gov

Verified2026-09-16

Review by2026-11-15

DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

BESTNOVO MEDICAL TECHNOLOGY Date Published : 06/23/2020 Fl 4 , No. 73 Bldg G57 , Taizhou, CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/23/2020 Desc: BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 06/23/2020 Desc: BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/23/2020 Desc: BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit

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

Source

accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.

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BESTNOVO MEDICAL TECHNOLOGY · 89-08 · CHINA

What the source says

Source

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