Import Of Covid 19 Antigen Test Kit In US

Covid 19 antigen test kit and other in vitro diagnostic devices (IVDs) are FDA-regulated products that require FDA and Customs and Border Protection (CBP) clearance when imported into the US. The FDA regulates imported medical devices and IVDs. Generally, imported devices must have FDA marketing approval or must be authorized under an approved Investigational Device Exemption (IDE), or other FDA-approved application or exemption. Devices that cannot meet these criteria are often refused entry by the FDA.

Covid 19 antigen test kit, by contrast, could help to rapidly identify people who have high levels of virus — those who are most likely to be infectious to others — and isolate them from the community. 

Covid 19 antigen test kit – In US

The Covid 19 antigen test kit detect specific proteins — known as antigens — on the surface of the virus, and can identify people who are at the peak of infection, when virus levels in the body are likely to be high.  Proponents argue that this could be a game changer. Covid 19 antigen test kit could help to keep the pandemic at bay, because they can be rolled out in vast numbers and can spot those who are at greatest risk of spreading the disease. 

These tests are also a key element in the testing strategies of other countries, such as India and Italy. Covid 19 antigen test kit are much faster and cheaper than the gold-standard tests that detect viral RNA using a technique called the polymerase chain reaction (PCR).But antigen tests aren’t as sensitive as the PCR versions, which can pick up minuscule amounts of the SARS-CoV-2 virus that causes COVID-19. Covid 19 antigen test kit give results in less than 30 minutes, don’t have to be processed in a lab and are cheap to produce. Yet that speed comes with a cost in sensitivity. 

Import covid 19 antigen test kit

When importing Covid 19 antigen test kit or devices, importers must provide product details and specify which FDA authorizations apply to the devices in order to obtain a Customs and FDA release. Failure to declare the imported devices correctly may result in clearance delays or entry refusal by the agencies. To facilitate access to Covid 19 antigen test kit, the FDA has issued Emergency Use Authorization (EUA) and enforcement discretion policies that allow certain COVID-19 IVDs to be imported and marketed in the US. 

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