ZHUHAI LIVZON DIAGNOSTICS Inc · 89-08 · CHINA
For ZHUHAI LIVZON DIAGNOSTICS Inc · 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 Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold) | Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold) | COVID-19 Diagnostic Kit for IgM/IgG Antibody to Corona Virus (nCoV-2019)(Colloidal Gold) | Livzon Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow) | Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold); product code is 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; date published is 07/17/2020; address is No. 266 Tongchang Road , Zhuhai, Guangdong CHINA, verified against its source on 2026-09-16.
- Firm
- ZHUHAI LIVZON DIAGNOSTICS Inc 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. 266 Tongchang Road , Zhuhai, Guangdong CHINA verified
- Date published
- 07/17/2020 verified
- Product code
- 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. each item verified
- Product
- Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold) | Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold) | COVID-19 Diagnostic Kit for IgM/IgG Antibody to Corona Virus (nCoV-2019)(Colloidal Gold) | Livzon Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow) | Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold) each item verified
What the source says
ZHUHAI LIVZON DIAGNOSTICS Inc Date Published : 07/17/2020 No. 266 Tongchang Road , Zhuhai, Guangdong CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/17/2020 Desc: Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold) 83 Q - - KO Reagent, coronavirus serological Date Published: 07/17/2020 Desc: Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold) 83 Q - - KO Reagent, coronavirus serological Date Published: 08/25/2021 Desc: COVID-19 Diagnostic Kit for IgM/IgG Antibody to Corona Virus (nCoV-2019)(Colloidal Gold) 83 Q - - KO Reagent, coronavirus serological Date Published: 03/23/2021 Desc: Livzon Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/17/2020 Desc: Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html