About Bases2FastqDx
This page lists the intended use, device identification, and regulatory markings for Bases2FastqDx.
Intended use
The AVITI Dx System product family delivers precise, high-quality raw DNA sequencing data from a variety of biological samples. The product is intended solely as a data generation tool and does not provide diagnostic interpretations or direct clinical recommendations.
Device identification
| Identifier | Value |
|---|---|
| UDI-DI | Bases2fastq 00860015636072 |
Regulatory markings
| Symbol | Description | Details |
|---|---|---|
 | European Conformity (CE) Marking | — |
 | Authorized representative (EC REP) | QbD RepS BV Groenenborgerlaan 16 2610 Wilrijk, Belgium SRN: BE-AR-000000040 |