# HANGZHOU REALY TECH CO LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Zhi Jiang Ming Lou #12 4th Flr , Eastern Medicine; Jianggan , Hangzhou, Zhejiang CHINA _(verified: appears in the quote below)_
- **Date published:** 10/19/2020 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).