# GENELOGIC RESEARCH LIMITED · 89-08 · HONG KONG SAR — FDA import alert red lists: firms subject to detention without physical examination

For GENELOGIC RESEARCH 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 Genelogic COVID-19 IgM/IgG Antibody Rapid Test | SARS-CoV-2 IgM/IgG Antibody Lateral Flow Assay; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 05/14/2021; address is Unit 349, 3f, Building , Shatin, HONG KONG SAR, verified against its source on 2026-09-16.

- **Firm:** GENELOGIC RESEARCH LIMITED _(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:** Unit 349, 3f, Building , Shatin, HONG KONG SAR _(verified: appears in the quote below)_
- **Date published:** 05/14/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological _(verified: each item appears in the quote below)_
- **Product:** Genelogic COVID-19 IgM/IgG Antibody Rapid Test | SARS-CoV-2 IgM/IgG Antibody Lateral Flow Assay _(verified: each item appears in the quote below)_

## What the source says

> GENELOGIC RESEARCH LIMITED Date Published : 05/14/2021 Unit 349, 3f, Building , Shatin, HONG KONG SAR 83 Q - - KO Reagent, coronavirus serological Date Published: 05/14/2021 Desc: Genelogic COVID-19 IgM/IgG Antibody Rapid Test 83 Q - - KO Reagent, coronavirus serological Date Published: 05/14/2021 Desc: SARS-CoV-2 IgM/IgG Antibody Lateral Flow Assay

## 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/).