MOLOGIC LTD · 89-08 · UNITED KINGDOM
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
- 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
- Address
- Bedford Technology Park , Bedfordshire, UNITED KINGDOM verified
- Date published
- 05/14/2021 verified
- 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. each item verified
- 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 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html