-
FDA issues Emergency Use Authorization for Oral CovAb™ SARS-CoV-2 Ab Test
americanpharmaceuticalreview
June 25, 2021
Diabetomics, Inc., announced the granting of an Emergency Use Authorization (EUA) by the US FDA for the Company's CovAb™ SARS-CoV-2 Ab point-of-care test. The product had also received a CE mark for marketing in the EU earlier.
-
Researchers develop COVID-19 antibody test to detect new variants
pharmatimes
June 18, 2021
New antibody tests that can detect if an individual has been exposed to COVID-19 variants have been developed by scientists from the University of Aberdeen.
-
ADEXUSDx COVID-19 Antibody Test Filed for EUA Confirmed 100% Accurate with BEI Panel
americanpharmaceuticalreview
December 28, 2020
NOWDiagnostics has announced study results for its ADEXUSDx® COVID-19 antibody test yielded encouraging test performance—providing a strong use case for the innovative diagnostic device, which was filed for Emergency Use Authorization (EUA) from ...
-
Liquid Diagnostics Develops Unique Saliva COVID-19 Antibody Test
prnewswire
December 09, 2020
Liquid Diagnostics announced today the development and successful CLIA validation of a home-collection assay for the quantitative testing of COVID-19 antibodies using saliva.
-
Everlywell Signs Agreement to Distribute Cellex Covid-19 Rapid Antigen Test for Organizations and Public Health Agencies
prnewswire
December 08, 2020
Everlywell announced it has entered into a distribution agreement with diagnostics manufacturer Cellex, the first company to receive an FDA Emergency Use Authorization for a COVID-19 antibody test.
-
FlowMetric Launches COVID-19 Antibody Test
americanpharmaceuticalreview
December 07, 2020
FlowMetric Life Sciences has created and brought to market a COVID-19 antibody test.
-
Kantaro Receives FDA Emergency Use Authorization for Semi-Quantitative COVID-19 Antibody Test Kit that Detects the Presence and Level of SARS-CoV-2 IgG Antibodies
prnewswire
November 26, 2020
Kantaro Biosciences, LLC, a joint venture between the Mount Sinai Health System and RenalytixAI, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for COVID-SeroKlir, its semi-quantitative SARS-CoV-2 IgG ...
-
Kroger Health Launches COVID-19 Rapid Antibody Testing at Pharmacy Locations
prnewswire
October 29, 2020
Kroger Health, the healthcare division of The Kroger Co., announced the launch of rapid antibody testing across its family of pharmacies, expanding the company's existing portfolio of in-clinic and at-home COVID-19 diagnostic tests ...
-
BreviTest's COVID-19 IgG Antibody Test Receives FDA Commercial Distribution Approval
americanpharmaceuticalreview
September 07, 2020
BreviTest Technologies announced the U.S. Food and Drug Administration (FDA) has officially accepted BreviTest's official notification of its intent to commercially distribute its IgG antibody test under policy outlined in Section IV.D. of the Policy ...
-
Truvian Receives FDA Emergency Use Authorization for COVID-19 IgM/IgG Test
americanpharmaceuticalreview
August 05, 2020
Truvian Sciences announced the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company's Easy Check COVID-19 IgM/IgGTM antibody test.