C&C Clinical Laboratory Consulting

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C&C Clinical Laboratory Consulting C&C Clinical Laboratory Consulting is here for all your CLIA compliance needs. Visit us at
www.cclabconsult.com.com

We specialize in helping physician office or hospital laboratories achieve and maintain compliance.

If you are trying to bring COVID-19 serology testing into your laboratory, the FDA has created a nice summary of the per...
17/06/2020

If you are trying to bring COVID-19 serology testing into your laboratory, the FDA has created a nice summary of the performance of each test it has granted an EUA for. Use this to help choose the correct test for your lab. And remember, at this time there are NO waived serology tests available! You must be a moderate or high complexity lab for most of these tests. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance

EUA Authorized Serology Test Performance

There is a new FDA announcement today if you are using the Chembio antibody test in your lab.  https://www.fda.gov/news-...
17/06/2020

There is a new FDA announcement today if you are using the Chembio antibody test in your lab. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chembio-antibody-test?utm_campaign=2020-06-16%20FDA%20Revokes%20Emergency%20Use%20Authorization%20%28EUA%29%20for%20Chembio%20Antibody%20Test&utm_medium=email&utm_source=Eloqua

FDA revoked the emergency use authorization of the Chembio Diagnostic System, Inc. DPP COVID-19 IgM/IgG System SARS-CoV-2 antibody test

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