OMEGA DIAGNOSTICS LTD · 89-08 · UNITED KINGDOM
For OMEGA DIAGNOSTICS LTD, import alert is 89-08; country is UNITED KINGDOM; 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 Global Access Diagnostics (GAD) COVID-19 Antigen Rapid Diagnostic Test | Omega VISITECT COVID-19 Antigen Rapid Diagnostic Test (RDT); product code is 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 04/01/2022; address is Eden Research Park , Littleport, UNITED KINGDOM, verified against its source on 2026-09-30.
- Firm
- OMEGA DIAGNOSTICS 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
- Eden Research Park , Littleport, UNITED KINGDOM verified
- Date published
- 04/01/2022 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- Global Access Diagnostics (GAD) COVID-19 Antigen Rapid Diagnostic Test | Omega VISITECT COVID-19 Antigen Rapid Diagnostic Test (RDT) each item verified
What the source says
OMEGA DIAGNOSTICS LTD Date Published : 04/01/2022 Eden Research Park , Littleport, UNITED KINGDOM
— accessdata.fda.gov, retrieved 2026-09-22
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 - - KP Coronavirus antigen detection test system. Date Published: 04/01/2022 Desc: Global Access Diagnostics (GAD) COVID-19 Antigen Rapid Diagnostic Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/01/2022 Desc: Omega VISITECT COVID-19 Antigen Rapid Diagnostic Test (RDT)
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html