# H-GUARD (CHINA) CO LTD · 89-08 · HONG KONG SAR — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 7a The , 76a Fa Yuen Street , Mong Kok, Kowloon HONG KONG SAR _(verified: appears in the quote below)_
- **Date published:** 07/17/2020 _(verified: appears in the quote below)_
- **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. _(verified: each item appears in the quote below)_
- **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) _(verified: each item appears in the quote below)_

## 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)

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).