HANGZHOU REALY TECH CO LTD · 89-08 · CHINA
For HANGZHOU REALY TECH CO LTD, import alert is 89-08; country is CHINA; 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)"; product is 2019nCOV IgG/IgM Rapid Test | Realy New Coronavirus Covid19 Rapid test | Anti SARS CoV 2 IgG/IgM Rapid Test Device | 2019nCOV IgG/IgM Rapid Test | Realy New Coronavirus Covid19 Rapid test | Anti SARS CoV 2 IgG/IgM Rapid Test Device | 2019nCOV IgG/IgM Rapid Test | Realy New Coronavirus Covid19 Rapid test | Anti SARS CoV 2 IgG/IgM Rapid Test Device | 2019nCOV IgG/IgM Rapid Test | Anti SARS CoV 2 IgG/IgM Rapid Test Device | Realy New Coronavirus Covid19 Rapid test; 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 2026-09-30.
- 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
- 2019nCOV IgG/IgM Rapid Test | Realy New Coronavirus Covid19 Rapid test | Anti SARS CoV 2 IgG/IgM Rapid Test Device | 2019nCOV IgG/IgM Rapid Test | Realy New Coronavirus Covid19 Rapid test | Anti SARS CoV 2 IgG/IgM Rapid Test Device | 2019nCOV IgG/IgM Rapid Test | Realy New Coronavirus Covid19 Rapid test | Anti SARS CoV 2 IgG/IgM Rapid Test Device | 2019nCOV IgG/IgM Rapid Test | Anti SARS CoV 2 IgG/IgM Rapid Test Device | Realy New Coronavirus Covid19 Rapid test each item verified
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
— accessdata.fda.gov, retrieved 2026-09-22
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
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 - - JR Reagents, 2019-novel coronavirus nucleic acid 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 - - 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 - - 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: 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 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/19/2020 Desc: Realy New Coronavirus Covid19 Rapid test
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html