# SAFECARE BIOTECH(HANGZHOU)CO.,LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For SAFECARE BIOTECH(HANGZHOU)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 Covid-19 IgG/IgM Rapid Test (Whole Blood Plasma) | COVID-19 IgG/IgM Rapid Test Device | SAFECARE 2019nCoV IgG/IgM Rapid Test | Covid-19 IgG/IgM Rapid Test (Whole Blood Plasma) | SAFECARE 2019nCoV IgG/IgM Rapid Test | COVID-19 IgG/IgM Rapid Test Device | COVID-19 IgG/IgM Rapid Test Device | Covid-19 IgG/IgM Rapid Test (Whole Blood Plasma) | SAFECARE 2019nCoV IgG/IgM 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; date published is 07/17/2020; address is No.689, Changxing Avenue, Taihu Street, Changxing County , Huzhou , Zhejiang CHINA, verified against its source on 2026-09-16.

- **Firm:** SAFECARE BIOTECH(HANGZHOU)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:** No.689, Changxing Avenue, Taihu Street, Changxing County , Huzhou , Zhejiang CHINA _(verified: appears in the quote below)_
- **Date published:** 07/17/2020 _(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. _(verified: each item appears in the quote below)_
- **Product:** Covid-19 IgG/IgM Rapid Test (Whole Blood Plasma) | COVID-19 IgG/IgM Rapid Test Device | SAFECARE 2019nCoV IgG/IgM Rapid Test | Covid-19 IgG/IgM Rapid Test (Whole Blood Plasma) | SAFECARE 2019nCoV IgG/IgM Rapid Test | COVID-19 IgG/IgM Rapid Test Device | COVID-19 IgG/IgM Rapid Test Device | Covid-19 IgG/IgM Rapid Test (Whole Blood Plasma) | SAFECARE 2019nCoV IgG/IgM Rapid Test _(verified: each item appears in the quote below)_

## What the source says

> SAFECARE BIOTECH(HANGZHOU)CO.,LTD Date Published : 07/17/2020 No.689, Changxing Avenue, Taihu Street, Changxing County , Huzhou , Zhejiang CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/17/2020 Desc: Covid-19 IgG/IgM Rapid Test (Whole Blood Plasma) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/02/2020 Desc: COVID-19 IgG/IgM Rapid Test Device 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/02/2020 Desc: SAFECARE 2019nCoV IgG/IgM Rapid Test 83 Q - - KO Reagent, coronavirus serological Date Published: 07/17/2020 Desc: Covid-19 IgG/IgM Rapid Test (Whole Blood Plasma) 83 Q - - KO Reagent, coronavirus serological Date Published: 09/02/2020 Desc: SAFECARE 2019nCoV IgG/IgM Rapid Test 83 Q - - KO Reagent, coronavirus serological Date Published: 09/02/2020 Desc: COVID-19 IgG/IgM Rapid Test Device 83 Q - - KP Coronavirus antigen detection test system. Date Published: 09/02/2020 Desc: COVID-19 IgG/IgM Rapid Test Device 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/17/2020 Desc: Covid-19 IgG/IgM Rapid Test (Whole Blood Plasma) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 09/02/2020 Desc: SAFECARE 2019nCoV IgG/IgM Rapid Test

## 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/).