HANGZHOU REALY TECH CO LTD · 89-08 · CHINA

For HANGZHOU REALY TECH 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 Anti SARS CoV 2 IgG/IgM Rapid Test Device | 2019nCOV IgG/IgM Rapid Test | Realy New Coronavirus Covid19 Rapid test | Realy New Coronavirus Covid19 Rapid test | Anti SARS CoV 2 IgG/IgM Rapid Test Device | 2019nCOV IgG/IgM Rapid Test | 2019nCOV IgG/IgM Rapid Test | Realy New Coronavirus Covid19 Rapid test | Anti SARS CoV 2 IgG/IgM Rapid Test Device | Realy New Coronavirus Covid19 Rapid test | 2019nCOV IgG/IgM Rapid Test | Anti SARS CoV 2 IgG/IgM Rapid Test Device; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 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 - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 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 | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 10/19/2020; address is Zhi Jiang Ming Lou #12 4th Flr , Eastern Medicine; Jianggan , Hangzhou, Zhejiang CHINA, verified against its source on 2026-09-16.

Firm: HANGZHOU REALY TECH 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: Zhi Jiang Ming Lou #12 4th Flr , Eastern Medicine; Jianggan , Hangzhou, Zhejiang CHINA verified
Date published: 10/19/2020 verified
Product code: 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 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 - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 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 | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices each item verified
Product: Anti SARS CoV 2 IgG/IgM Rapid Test Device | 2019nCOV IgG/IgM Rapid Test | Realy New Coronavirus Covid19 Rapid test | Realy New Coronavirus Covid19 Rapid test | Anti SARS CoV 2 IgG/IgM Rapid Test Device | 2019nCOV IgG/IgM Rapid Test | 2019nCOV IgG/IgM Rapid Test | Realy New Coronavirus Covid19 Rapid test | Anti SARS CoV 2 IgG/IgM Rapid Test Device | Realy New Coronavirus Covid19 Rapid test | 2019nCOV IgG/IgM Rapid Test | Anti SARS CoV 2 IgG/IgM Rapid Test Device 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

HANGZHOU REALY TECH CO LTD Date Published : 10/19/2020 Zhi Jiang Ming Lou #12 4th Flr , Eastern Medicine; Jianggan , Hangzhou, Zhejiang CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/19/2020 Desc: Anti SARS CoV 2 IgG/IgM Rapid Test Device 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/19/2020 Desc: 2019nCOV IgG/IgM Rapid Test 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/19/2020 Desc: Realy New Coronavirus Covid19 Rapid test 83 Q - - KO Reagent, coronavirus serological Date Published: 10/19/2020 Desc: Realy New Coronavirus Covid19 Rapid test 83 Q - - KO Reagent, coronavirus serological Date Published: 10/19/2020 Desc: Anti SARS CoV 2 IgG/IgM Rapid Test Device 83 Q - - KO Reagent, coronavirus serological Date Published: 10/19/2020 Desc: 2019nCOV IgG/IgM Rapid Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/19/2020 Desc: 2019nCOV IgG/IgM Rapid Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/19/2020 Desc: Realy New Coronavirus Covid19 Rapid test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/19/2020 Desc: Anti SARS CoV 2 IgG/IgM Rapid Test Device 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/19/2020 Desc: Realy New Coronavirus Covid19 Rapid test 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/19/2020 Desc: 2019nCOV IgG/IgM Rapid Test 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/19/2020 Desc: Anti SARS CoV 2 IgG/IgM Rapid Test Device

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

Source

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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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HANGZHOU REALY TECH CO LTD · 89-08 · CHINA

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