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

By LabPulse.com staff writers

May 22, 2020 -- 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
AACC objects to FDA's at-home virus kit clearance, following go-ahead for Everlywell
The American Association for Clinical Chemistry (AACC) has notified the U.S. Food and Drug Administration (FDA) that it objects to the agency's recent...
FDA authorizes home COVID-19 nasal sample kit
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Everlywell's at-home nasal sample collection kit for COVID-19...
FDA grants 1st clearance of at-home saliva test for coronavirus
The U.S. Food and Drug Administration (FDA) has granted the first clearance of an at-home saliva test for SARS-CoV-2 to Rutgers Clinical Genomics Laboratory...
Seasun Biomaterials to launch COVID-19 assay
Seasun Biomaterials plans to release its second COVID-19 assay following emergency use authorization from the U.S. Food Drug Administration.

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Last Updated ls 5/22/2020 3:50:56 PM