Covid 19抗原测试套件和其他体外诊断装置（IVDS）是FDA调节产品，要求在进口到美国时的FDA和海关和边境保护（CBP）清除。FDA调节进口医疗设备和IVD。通常，进口设备必须具有FDA营销批准，或者必须根据批准的调查设备豁免（IDE）或其他FDA批准的申请或豁免授权。无法满足这些标准的设备通常由FDA拒绝进入。
Covid 19抗原测试套件, 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.
- Operon Strategist isFDA 510 K流程consultant helps the clients to register SBU (Small Business Unit), if applicable.
- Take out the testing requirement of the product, creation of the dossier, resolving the queries and after completion of all the activities, the client receives the US FDA 510 k approval.
- We also assist with the establishment registration and device listings to make suitable the supply of medical devices in the US.
A typicalCovid 19抗原测试套件始于一个医疗专业抽汲the back of a person’s nose or throat — although companies are developing kits that use saliva samples, which are easier and safer to collect than a swab. The sample is then mixed with a solution that breaks the virus open and frees specific viral proteins.将混合物添加到纸条中，含有抗体，用于与这些蛋白质结合的抗体，如果它们存在于溶液中。可以将正测试结果作为荧光发光或纸条上的暗带进行检测。
As of early May 2020, over 4.7 million people have been confirmed to be infected with the SARS-CoV-2 coronavirus, and governments are scrambling to contain its spread. The high R0 value (a measure of contagiousness- estimated to be between 2.0 and 3.02) of SARS-CoV-2 means that those infected copiously spread the virus and develop complications suddenly. As a result, health care systems are overwhelmed, and the effective delivery of medical care to all patients has become a challenge worldwide
Covid 19抗原测试套件 - 在美国
TheCovid 19抗原测试套件检测特定的蛋白质 - 称为抗原 - 在病毒的表面上，并且可以识别在感染峰的峰值时，当体内的病毒水平可能很高时。Proponents argue that this could be a game changer.Covid 19抗原测试套件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抗原测试套件比使用称为聚合酶链反应（PCR）的技术检测病毒RNA的金标准测试更快和更便宜。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抗原测试套件在不到30分钟的时间内给出结果，不必在实验室中加工，并廉价生产。然而，速度具有敏感性的成本。
虽然典型的PCR试验可以在微溶液中检测单个RNA分子，但抗原试验需要样品以含有数千次 - 可能每微小的病毒颗粒以产生阳性结果。
进口Covid 19抗原测试套件
When importingCovid 19抗原测试套件或设备，导入器必须提供产品详细信息并指定哪些FDA授权适用于设备，以获取海关和FDA发布。Failure to declare the imported devices correctly may result in clearance delays or entry refusal by the agencies.To facilitate access toCovid 19抗原测试套件此外，FDA已发出紧急使用授权（EUA），并执行允许某些Covid-19 IVDS在美国进口和销售的自由裁量权政策。
These FDA policies support trade by lifting some the restrictions that normally apply to the import of medical devices.All COVID-19 test kits that are already certified and with pending application for Special Certification with FDA prior to the effectivity of this Memorandum shall comply with the above-specified minimum performance requirements based on the performance validation.
The US FDA has so far granted emergency use authorization for four antigen tests, each of which has a higher sensitivity than those used in India. The 150 million tests have been bought and will be used in schools and “other special needs populations”, according to the Department of Health and Human Services. The FDA, however, has authorized COVID-19 antigentest kits -based tests only for people who have had symptoms for 12 days or fewer. Tests must be prescribed by a physician and administered by a health-care professional.