GLOBAL ACCESS DIAGNOSTICS · 89-08 · UNITED KINGDOM
For GLOBAL ACCESS DIAGNOSTICS · 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 Omega VISITECT COVID-19 Antigen Rapid Diagnostic Test (RDT) | Global Access Diagnostics (GAD) COVID-19 Antigen Rapid Diagnostic Test; 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 Bedford Technology Park , Thurleigh, UNITED KINGDOM, verified against its source on 2026-09-16.
- Firm
- GLOBAL ACCESS DIAGNOSTICS 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 , Thurleigh, 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
- 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
GLOBAL ACCESS DIAGNOSTICS Date Published : 04/01/2022 Bedford Technology Park , Thurleigh, UNITED KINGDOM 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/01/2022 Desc: Omega VISITECT COVID-19 Antigen Rapid Diagnostic Test (RDT) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/01/2022 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
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