510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QTANot classified

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

Unknown
FDA source (opens on fda.gov)

QTA is the FDA product code for Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QTA
Device name
Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis
FDA 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.
Device class
Not classified
Review panel
Unknown
Submission type
FDA code 8
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QTA.