# Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QTA)
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