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EUA-Color-SARSDx-Rev-2021-07-09 (002)
July 9, 2021
Alicia Y. Zhou, PhD Chief Scientific Officer Color Health, Inc. 831 Mitten Road, Suite 100 Burlingame, CA 94010
Re: EUA200539/S010 Trade/Device Name: Color SARS-CoV-2 RT-LAMP Diagnostic Assay Dated: June 21, 2021 Received: June 22, 2021
Dear Dr. Zhou:
This is to notify you that your request to update the authorized labeling of the Color SARS-CoV-2 RT-LAMP Diagnostic Assay to change the assay format to include an initial screening assay followed by reflex testing for invalid results and "candidate" positive specimens, is granted. Upon review, we concur that the data and information submitted in EUA200539/S010 supports the requested updates for use with the Color SARS-CoV-2 RTLAMP Diagnostic Assay. By submitting this EUA revision for review by the Food and Drug Administration (FDA), you have complied with the Conditions of Authorization stated in the letter authorizing the emergency use of the Color SARS-CoV-2 RT-LAMP Diagnostic Assay reissued on April 14, 2021.
Sincerely yours,
____________________________ Uwe Scherf, M.Sc., Ph.D. Director, Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20903 www.fda.gov
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