Sentosa SA BCR-ABL minor Quantitative RT-PCR Test v2.0 (4x8)

Primary DI

08885013953947

Basic UDI-DI Code

B-08885013953947

Reference

300755

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® SA BCR-ABL minor Quantitative RT-PCR Test v2.0 (4x8) is a singleplex, real-time PCR based in vitro diagnostic test. This test is intended for automated nucleic acid extraction from peripheral blood samples on the Sentosa® SX101 using the Sentosa® SX Total RNA Kit (4x8), and for in vitro quantitation of BCR-ABL minor fusion gene transcripts in leukemia patients who have been diagnosed with BCRABL minor with e1a2 fusion gene transcripts, using the Rotor-Gene® Q MDx 5plex HRM instrument. The test can be used at prognostic stage to observe the drug treatment effects or as a supplementary approach for diagnosis. It should not be used as the sole basis to make diagnostic decisions. The results from Sentosa® SA BCR-ABL minor Quantitative RT-PCR Test v2.0 (4x8) should be interpreted within the context of all relevant clinical and laboratory findings

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