GENELOGIC RESEARCH LIMITED · 89-08 · HONG KONG SAR
For GENELOGIC RESEARCH LIMITED, import alert is 89-08; country is HONG KONG SAR; 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)"; 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 2026-09-30.
- Firm
- GENELOGIC RESEARCH 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
- Unit 349, 3f, Building , Shatin, HONG KONG SAR verified
- Date published
- 05/14/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- Genelogic COVID-19 IgM/IgG Antibody Rapid Test | SARS-CoV-2 IgM/IgG Antibody Lateral Flow Assay each item verified
What the source says
GENELOGIC RESEARCH LIMITED Date Published : 05/14/2021 Unit 349, 3f, Building , Shatin, HONG KONG SAR
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html