As you know, the pandemic situation has changed the healthcare landscape and as professionals, we must ensure that whatever services we provide meets requirements. As such we have taken all precautions to find reputable supplies with ample supply to help our colleagues provide necessary testing which to the best of our research has met all requirements.
We have sourced the following tests which have provided us with all documents about their tests. An “Emergency Use Authorization- EUA” has been granted by the FDA to all tests that have submitted required documents. Click here to see a complete up-to-date list. Hangzhou Biotest Biotech is listed according to the site and the EUA not required indicates that FDA allows commercial manufacturers to launch serology tests without an EUA.
As you can see from the FDA letter included here, Coronacide acknowledgment letter dated March 18, 2020, FDA has received their document and has been granted a PEUA number. Our supplier since then has acquired the right to Coronacide and changed the name to CoronaCheck.
As a colleague we want you to be aware of all the due diligence we have made to ensure that we provide you a CLIA waived test that to the best of our knowledge is okay to use. We do not accept any responsibility or claim anything other than what is provided to us. After you review the attached documents and still would like us to send you the tests simply respond back to me and I will expedite your order.
We wish you all the best – stay safe.