H-GUARD (CHINA) CO LTD · 89-08 · HONG KONG SAR
For H-GUARD (CHINA) CO LTD · 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 Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold) | Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold) | Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold); 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; date published is 07/17/2020; address is 7a The , 76a Fa Yuen Street , Mong Kok, Kowloon HONG KONG SAR, verified against its source on 2026-09-16.
- Firm
- H-GUARD (CHINA) 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
- HONG KONG SAR verified
- Address
- 7a The , 76a Fa Yuen Street , Mong Kok, Kowloon HONG KONG SAR 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 - - KP Coronavirus antigen detection test system. each item verified
- Product
- Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold) | Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold) | Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold) each item verified
What the source says
H-GUARD (CHINA) CO LTD Date Published : 07/17/2020 7a The , 76a Fa Yuen Street , Mong Kok, Kowloon HONG KONG SAR 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/17/2020 Desc: Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold) 83 Q - - KO Reagent, coronavirus serological Date Published: 07/17/2020 Desc: Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/17/2020 Desc: Novel Coronavirus COVID-19 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