FDA has requested that certain serology tests, inc
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Posted On: 12/06/2020 3:32:35 PM
FDA has requested that certain serology tests, including lateral flow serology assays (IgM, IgG, etc.) and certain enzyme-linked immunosorbent assay (ELISA) or similar technology-based SARS-CoV-2 antibody tests, be independently evaluated by the NIH/NCI prior to authorization. FDA may leverage data from testing at the NCI/NIH, or at another federal government laboratory designated by FDA, to inform decisions on EUA requests and other actions.
If you are interested in participating in this independent evaluation, please send an email to CDRH-OIR-POPS@fda.hhs.gov. Include the following information in your email:
-Manufacturer and test name as provided in your notification to FDA,
-Volume of tests currently available to distribute in the United States,
-Weekly production volume available to distribute in the United States,
-Test technology,
-Sample type, and
-Pre-EUA (PEUA) or EUA number if you have been assigned one.
https://www.fda.gov/medical-devices/coronavir...sars-cov-2
In Vitro Diagnostics EUAs
https://www.fda.gov/medical-devices/coronavir...al-antigen
If you are interested in participating in this independent evaluation, please send an email to CDRH-OIR-POPS@fda.hhs.gov. Include the following information in your email:
-Manufacturer and test name as provided in your notification to FDA,
-Volume of tests currently available to distribute in the United States,
-Weekly production volume available to distribute in the United States,
-Test technology,
-Sample type, and
-Pre-EUA (PEUA) or EUA number if you have been assigned one.
https://www.fda.gov/medical-devices/coronavir...sars-cov-2
In Vitro Diagnostics EUAs
https://www.fda.gov/medical-devices/coronavir...al-antigen
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