emergency use authorization approved

BioCode Gets Emergency Use Authorization for Coronavirus Test

June 17, 2020

California-based Applied BioCode has received an Emergency Use Authorization (EUA) from the FDA for its BioCode SARS-CoV-2 assay.

The polymerase-chain-reaction test detects nucleic acid from the coronavirus from upper respiratory specimens collected by healthcare providers.

Emergency use of the assay is limited to laboratories that are certified to perform high-complexity tests, the agency said.

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