7 results
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49ms
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Sources: EU EUDAMED, US FDA
EMPOWERED DIAGNOSTICS LLC
Manufacturer
🇺🇸 United States
COVCLEAR COVID TEST
FDA Adverse Event
Malfunction
·EMPOWERED DIAGNOSTICS LLC·Product code QKP·February 25, 2022
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
FDA Recall
Completed
·Empowered Diagnostics LLC·Product code QKO·December 22, 2021
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
FDA Recall
Completed
·Empowered Diagnostics LLC·Product code QKP·December 22, 2021
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
FDA Enforcement
Class I
·Completed·Empowered Diagnostics LLC·February 9, 2022
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
FDA Enforcement
Class I
·Completed·Empowered Diagnostics LLC·February 9, 2022
EUCEREP B.V.
Authorized representative
🇳🇱 Netherlands·19 Manufacturers·66 Devices