Genesprint Group Limited · 89-08 · HONG KONG SAR
For Genesprint Group Limited · 89-08 · HONG KONG SAR, 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 HONG KONG SAR; product is 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) | 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) | 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) | 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based); product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 10/21/2020; address is 20/F, Flat 2, Flat 2 , Malaysia Building; 50 Gloucester Road , Wan Chai, Hong Kong Island HONG KONG SAR, verified against its source on 2026-09-16.
- Firm
- Genesprint Group Limited 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
- HONG KONG SAR verified
- Address
- 20/F, Flat 2, Flat 2 , Malaysia Building; 50 Gloucester Road , Wan Chai, Hong Kong Island HONG KONG SAR verified
- Date published
- 10/21/2020 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices each item verified
- Product
- 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) | 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) | 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) | 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) each item verified
What the source says
Genesprint Group Limited Date Published : 10/21/2020 20/F, Flat 2, Flat 2 , Malaysia Building; 50 Gloucester Road , Wan Chai, Hong Kong Island HONG KONG SAR 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/21/2020 Desc: 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) 83 Q - - KO Reagent, coronavirus serological Date Published: 10/21/2020 Desc: 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/21/2020 Desc: 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/21/2020 Desc: 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html