FDA Virtual Town Hall for Clinical Laboratories and Manufacturers
On each Wednesday in July, FDA will host a virtual meeting to answer technical questions about the development and validation of tests for SARS-CoV-2.
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Search Results for: covid-19
Beckman Coulter’s SARS-CoV-2 IgG Antibody Test Receives FDA EUA
Beckman Coulter has shipped tests to more than 400 hospitals, clinics, and diagnostic laboratories in the United States and has begun distribution globally.
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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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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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