Babson Diagnostics Receives FDA EUA for SARS-CoV-2 IgG Antibody Test
The aC19G1 is a covid-19 serology test that enables the qualitative detection of IgG antibodies to SARS-CoV-2 with 100% sensitivity and 100% specificity.
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Search Results for: covid-19
Hoowaki Introduces One-Piece Injection-Molded Swab
Production can be ramped up to help meet the need for testing supplies for covid-19.
Read MoreFDA Updates Templates for Serology Test EUA Requests
The updates clarify FDA’s previous recommendations for demonstrating clinical performance and presenting validation data and provide new recommendations.
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Applied BioCode SARS-CoV-2 Assay Granted FDA EUA
The nucleic acid assay is for the qualitative detection of SARS-CoV-2 nucleic acids in respiratory samples from individuals who are suspected of covid-19.
Read MoreFDA Warning Letters to Companies Inappropriately Marketing Antibody Tests
The action is an effort to help protect public health from fraudulent products.
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