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PGDx elio™ server

B-01-40800 · Personal Genome Diagnostics Inc.

PGDx elio™ server (reconditioned 128C)

Details

Device typeCancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT): A collection of reagents and other associated materials intended for the qualitative and/or quantitative detection of mRNA expression and/or determination of the gene mutation status of multiple genes associated with cancer in a clinical specimen, using a nucleic acid technique (NAT). It is intended to be used in one or more of the following: select treatment options; predict or monitor the response to cancer therapy; risk assessment of cancer development, recurrence or metastasis; and/or for tumour profiling (e.g., cell-free DNA or circulating tumour DNA screening).

FDA categoryNext Generation Sequencing Based Tumor Profiling Test

Device ID00192721001456

Catalog numberB-01-40800

AvailabilityPrescription

MRI safetyLabeling does not contain MRI Safety Information

Contact

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