A validated, FDA-regulated, CE-marked IVD sequencing reagent kit, offering improved quality scores compared to previous versions.
This product is only available in select locations. Please select the location where you would like this product to be shipped to see availability.
The MiSeqDx Reagent Kit v3 contains a single-use set of reagents and consumables for sequencing libraries prepared for validated assays. To help labs meet quality requirements and ensure operational stability in a regulated environment, the kit offers:
The MiSeqDx Reagent Kit v3 delivers higher cluster densities, read lengths, and quality scores compared to previous versions.
The MiSeqDx Reagent Kit v3 is an FDA-regulated Class I and CE-marked in vitro diagnostic (IVD) sequencing kit issued with a certificate of analysis, which labs can use to satisfy regulatory qualification activities.
Single-lot shipments reduce the potential for variability between lots, minimize revalidation costs, improve traceability, and support lab tracking needs.
The kit is manufactured under Good Manufacturing Practice (GMP) regulations and undergoes both individual component and kit lot testing to ensure high quality.
The Illumina MiSeqDx Reagent Kit v3 is a set of reagents and consumables intended for sequencing of sample libraries when used with validated assays. The MiSeqDx Reagent Kit v3 is intended for use with the MiSeqDx Instrument and analytical software.
For In Vitro Diagnostic Use
Contact an Illumina representative for regional availability.
| Assay time | 28 hr |
|---|---|
| Hands-on time | 10 min |
| Instruments | MiSeqDx Instrument |
| Nucleic acid type | DNA |
| Species category | Human |
| Technology | Sequencing |
The MiSeqDx Reagent Kit v3 is used by clinical laboratories for in vitro diagnostic testing and assay development on the MiSeqDx Instrument.
Develop your own IVD assays on the MiSeqDx Instrument.
Illumina offers next-generation sequencing-based molecular diagnostic options for clinical laboratories.
| Read length | No. of reads passing filter | Bases > Q30 | Maximum output | Total overall accuracy | Total overall reproducibility |
|---|---|---|---|---|---|
| 2 × 150 bp | > 15 million | ≥ 80% | > 5 Gb | ≥ 99.66% | ≥ 99.70% |
*See the MiSeqDx Instrument specification sheet for minimum run requirements needed to achieve desired accuracy and reproducibility levels.
MiSeq Dx Reagent Kit v3
20037124
Includes one flow cell and one prefilled cartridge containing clustering and sequencing reagents to support one run of sample libraries on the MiSeqDx System.
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The MiSeqDx Instrument is FDA-regulated and CE-marked and provides both diagnostic and research modes. The MiSeq System is for research use only. In vitro diagnostic (IVD) testing is only supported on the MiSeqDx Instrument.
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