New coronavirus emergency clearances: BioCore, SolGent, Seasun, P23 Labs

2019 05 02 23 38 2538 Check Mark 400

The U.S. Food and Drug Administration granted four new emergency use authorizations for COVID-19 polymerase chain reaction (PCR) testing products, including a test cleared for use with saliva samples collected at home from P23 Labs of Little Rock, AR.

Authorizations were granted to the following products on May 21:

  • P23 Labs' TaqPath SARS-CoV-2 Assay
  • BioCore's 2019-nCoV Real Time PCR kit
  • SolGent's DiaPlexQ Novel Coronavirus (2019-nCoV) detection kit
  • Seasun Biomaterials' AQ-TOP COVID-19 rapid detection kit
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