SAFECARE BIOTECH(HANGZHOU)CO.,LTD · 89-08 · CHINA
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
- 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
- No.689, Changxing Avenue, Taihu Street, Changxing County , Huzhou , Zhejiang CHINA verified
- Date published
- 07/17/2020 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. each item verified
- 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 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html