Philippine News Agency
FDA clarifies availability of Covid-19 test kits in PH
The Food and Drug Administration (FDA) has warned the public against purchasing unregistered coronavirus home test kits being sold online, stating that no COVID-19 testing kits have been registered or tested by the agency.
FDA officer-in-charge Health Undersecretary Eric Domingo advised that any advertisements or products sold online claiming to be COVID-19 test kits are unregistered.
The agency clarified that no company has complied with the minimum requirements for product registration, such as a License to Operate and a Certificate of Product Registration from recognized regulatory agencies or the WHO.
The FDA emphasized that these requirements are in place to safeguard public interest and ensure the safety and reliability of available test kits.
Domingo cautioned that buying these unregistered kits could lead to wasted money due to unreliable results, potentially yielding false positives or negatives, and that they might even be counterfeit.
The FDA assured that there will be no delay in the approval process once proper documentation is submitted.
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