QTA — Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis Class N
FDA product code QTA covers "Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QTA
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Unknown
- Implant
- No
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.