March 16, the FDA updated its “Policy for Diagnostic Tests
for Coronavirus Disease-2019 during the Public Health Emergency”
document.
https://www.fda.gov/media/135659/download
As a result, BioMedomics will be able to distribute our
COVID-19 IgM-IgG Antibody Rapid Test to any licensed healthcare
practitioner in the United States for diagnostic use starting on
March 17, 2020.
From BioMetrics quote request page (they can't keep up
with demand)
NOTE: Due to high demand and the need to fulfill existing
orders, BioMedomics is temporarily halting new orders for COVID-19
tests. Our company will continue to fill all existing orders, and
explore new ways to source materials and expand capacity to meet
the growing demand for our tests. We are committed to doing our
part to battle COVID-19.
The winner will be the company with the best supply chain.
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They took it down.
Posted by pmahoney on 24th of Mar 2020 at 08:33 pm
They took it down.
They need to remove the
Posted by pmahoney on 24th of Mar 2020 at 09:20 pm
They need to remove the "in-home test" part of the wording
Does the COVID test even
Posted by pmahoney on 25th of Mar 2020 at 01:04 am
Does the COVID test even need FDA approval???
https://www.biomedomics.com/latest-fda-guidance-allows-distribution-of-sars-cov-2-serology-tests-for-diagnostic-use/
March 16, the FDA updated its “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency” document. https://www.fda.gov/media/135659/download
As a result, BioMedomics will be able to distribute our COVID-19 IgM-IgG Antibody Rapid Test to any licensed healthcare practitioner in the United States for diagnostic use starting on March 17, 2020.
From BioMetrics quote request page (they can't keep up with demand)
NOTE: Due to high demand and the need to fulfill existing orders, BioMedomics is temporarily halting new orders for COVID-19 tests. Our company will continue to fill all existing orders, and explore new ways to source materials and expand capacity to meet the growing demand for our tests. We are committed to doing our part to battle COVID-19.
The winner will be the company with the best supply chain.