Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis
QTA · Not classified · Unknown
Classification
FDA Product Code
QTA
Device class
Not classified
Regulation
—
Review panel
MI
Medical specialty
Unknown
Submission type
8
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.