QTA

Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis

Product code

QTA

Device name

Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis

Device class

Class N

Medical specialty

Unknown

Marketing pathway

EUA - Emergency Use Authorization

FDA classification definition

This is an IVD test which utilizes a next generation sequencing (NGS) method performed on a high throughput sequencing platform. This test can identify and differentiate SARS-CoV-2 and support additional genetic analysis, when clinically indicated, from SARS-CoV-2-positive samples identified as positive using an EUA authorized diagnostic test. Testing is limited to designated laboratories.

Definition text from the FDA device classification database (U.S. federal government work, public domain).