HUNAN RUNKUN PHARMACEUTICAL CO · 89-08 · CHINA
For HUNAN RUNKUN PHARMACEUTICAL CO · 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 SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold) | SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold) | SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold) | SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold); product code is 83 G - - NX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 06/23/2020; address is Bld B Zhantao Tech Zhi , Hong Kong, CHINA, verified against its source on 2026-09-16.
- Firm
- HUNAN RUNKUN PHARMACEUTICAL CO 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
- Bld B Zhantao Tech Zhi , Hong Kong, CHINA verified
- Date published
- 06/23/2020 verified
- Product code
- 83 G - - NX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold) | SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold) | SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold) | SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold) each item verified
What the source says
HUNAN RUNKUN PHARMACEUTICAL CO Date Published : 06/23/2020 Bld B Zhantao Tech Zhi , Hong Kong, CHINA 83 G - - NX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C Date Published: 06/23/2020 Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/23/2020 Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold) 83 Q - - KO Reagent, coronavirus serological Date Published: 06/23/2020 Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/23/2020 Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html