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Home » Business, Policy & Funding » Regulatory News & FDA Approvals » Advanced Biological Laboratories Gets CE Mark for SARS-CoV-2 qPCR Assay

Advanced Biological Laboratories Gets CE Mark for SARS-CoV-2 qPCR Assay

Jul 07, 2020
|
staff reporter

NEW YORK ─ Advanced Biological Laboratories said on Monday that it has received CE-IVD marking for its UltraGene Combo2Screen SARS-CoV-2 qPCR assay, enabling its use in the European Union and other countries that accept the designation.

The Luxembourg-based firm said the qPCR detection kit has been validated with SARS-CoV-2 RNA extracted from nasopharyngeal swabs and saliva.

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