# MOLOGIC LTD · 89-08 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

For MOLOGIC LTD · 89-08 · UNITED KINGDOM, 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 UNITED KINGDOM; product is BioSURE COVID-19 IgG Antibody Rapid Test | BioSURE COVID-19 Antibody Self Test | BioSURE COVID-19 Antibody Rapid Test | Omega VISITECT COVID-19 Antigen Rapid Diagnostic Test (RDT) | Global Access Diagnostics (GAD) COVID-19 Antigen Rapid Diagnostic Test; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 05/14/2021; address is Bedford Technology Park , Bedfordshire, UNITED KINGDOM, verified against its source on 2026-09-16.

- **Firm:** MOLOGIC 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:** UNITED KINGDOM _(verified: appears in the quote below)_
- **Address:** Bedford Technology Park , Bedfordshire, UNITED KINGDOM _(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 | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. _(verified: each item appears in the quote below)_
- **Product:** BioSURE COVID-19 IgG Antibody Rapid Test | BioSURE COVID-19 Antibody Self Test | BioSURE COVID-19 Antibody Rapid Test | Omega VISITECT COVID-19 Antigen Rapid Diagnostic Test (RDT) | Global Access Diagnostics (GAD) COVID-19 Antigen Rapid Diagnostic Test _(verified: each item appears in the quote below)_

## What the source says

> MOLOGIC LTD Date Published : 05/14/2021 Bedford Technology Park , Bedfordshire, UNITED KINGDOM 83 Q - - KO Reagent, coronavirus serological Date Published: 05/14/2021 Desc: BioSURE COVID-19 IgG Antibody Rapid Test 83 Q - - KO Reagent, coronavirus serological Date Published: 05/14/2021 Desc: BioSURE COVID-19 Antibody Self Test 83 Q - - KO Reagent, coronavirus serological Date Published: 05/14/2021 Desc: BioSURE COVID-19 Antibody Rapid Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/04/2022 Desc: Omega VISITECT COVID-19 Antigen Rapid Diagnostic Test (RDT) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/04/2022 Desc: Global Access Diagnostics (GAD) COVID-19 Antigen Rapid Diagnostic Test

## 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/).