Bio-Rad QXDx BCR-ABL %IS Kit - HSA Registration DE0506252
Access comprehensive regulatory information for Bio-Rad QXDx BCR-ABL %IS Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0506252 and owned by Bio-Rad Laboratories. The device was registered on October 04, 2021.
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The QXDx BCR-ABL %IS test, performed on Bio-Rad’s QXDx Droplet Digital PCR System, is an in vitro nucleic acid amplification test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t(9;22) positive Chronic Myeloid Leukemia (CML) patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The test measures the e13a2 and/or e14a2 transcripts of BCR-ABL1, normalized to the ABL1 endogenous control. Results are reported as percent reduction from a baseline of 100% on the International Scale (%IS) and on a log molecular reduction (MR) scale. The test does not differentiate between e13a2 or e14a2 fusion transcripts and does not monitor other rare fusion transcripts resulting from t(9;22). This test is not intended for the diagnosis of CML. The measures of BCR-ABL1/ABL1 ratio is used for t(9;22) positive CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors.