Bio-Rad QXDx BCR-ABL %IS Kit

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Commercializzato da:

BIO-RAD LABORATORIES (SINGAPORE) PTE LTD

Classe:

Class C IVD

Prodotto da:

Bio-Rad Laboratories, Inc

Area terapeutica:

Hematology

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Models: QXDx BCR-ABL %IS Kit - 12006134

Data dell'autorizzazione:

2021-10-04