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

Primary DI

08885013953930

Basic UDI-DI Code

B-08885013953930

Reference

300753

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 Major Quantitative RT-PCR Test v2.0 (4x8) is a single-plex, real-time PCR based in vitro diagnostic test. This test is intended for use for nucleic acid extraction from peripheral blood samples on the Sentosa SX101 automated extraction and pipetting system, with the Sentosa SX Total RNA Kit (4x8) and the Rotor-Gene Q MDx 5plex HRM instrument for in vitro quantitation of BCR-ABL Major fusion gene transcripts in leukemia patients who have been diagnosed with BCR-ABL Major b2a2 and b3a2 translocations. 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 Major Quantitative RT-PCR Test v2.0 (4x8) should be interpreted within the context of all relevant clinical and laboratory findings.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).