RayBiotech Guangzhou China · 89-08 · CHINA
For RayBiotech Guangzhou China · 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 Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method) | Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method) | Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method) | Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method) | Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method) | QXD-3 COVIDNOW | Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method); product code is 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 - - 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 79 Ruihe Street , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.
- Firm
- RayBiotech Guangzhou China 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
- 79 Ruihe Street , Guangzhou, Guangdong 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 - - 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
- Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method) | Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method) | Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method) | Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method) | Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method) | QXD-3 COVIDNOW | Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method) each item verified
What the source says
RayBiotech Guangzhou China Date Published : 07/17/2020 79 Ruihe Street , Guangzhou, Guangdong CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/17/2020 Desc: Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/17/2020 Desc: Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method) 83 Q - - KO Reagent, coronavirus serological Date Published: 07/17/2020 Desc: Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method) 83 Q - - KO Reagent, coronavirus serological Date Published: 07/17/2020 Desc: Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/17/2020 Desc: Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/02/2021 Desc: QXD-3 COVIDNOW 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/17/2020 Desc: Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html