Eachy Biopharmaceuticals Co., Ltd · 89-08 · CHINA

For Eachy Biopharmaceuticals 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 AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) | AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay) | AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay) | AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) | AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay) | AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) | AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) | AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay); product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 10/22/2020; address is 5 Building F F , Suzhou, Jiangsu CHINA, verified against its source on 2026-09-16.

Firm: Eachy Biopharmaceuticals 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: 5 Building F F , Suzhou, Jiangsu CHINA verified
Date published: 10/22/2020 verified
Product code: 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices each item verified
Product: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) | AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay) | AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay) | AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) | AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay) | AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) | AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) | AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay) 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

Eachy Biopharmaceuticals Co., Ltd Date Published : 10/22/2020 5 Building F F , Suzhou, Jiangsu CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/22/2020 Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/22/2020 Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay) 83 Q - - KO Reagent, coronavirus serological Date Published: 10/22/2020 Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay) 83 Q - - KO Reagent, coronavirus serological Date Published: 10/22/2020 Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/22/2020 Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/22/2020 Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/22/2020 Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/22/2020 Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay)

— 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.

This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.

Eachy Biopharmaceuticals Co., Ltd · 89-08 · CHINA

What the source says

Source

More on food, drink and consumer products