Intended Use The in vitro diagnostic medical device for the quantitative detection of the BCR-ABL1 chromosomal translocation mRNA transcripts (types e13a2/b2a2 or e14a2/b3a2) and the ABL1 endogenous control mRNA transcript in peripheral blood specimens from patients previously diagnosed with chronic myelogenous leukemia (CML) using real time PCR. (However, it is not possible to determine the specific type of mRNA transcripts of BCR-ABL1).

Product Features

• MFDS approved [체외 수허 23-248호]
• Quantitative monitoring of BCR-ABL mRNA in patients with chronic myelogenous leukemia (CML)
• Results aligned to the IS lot-to-lot through secondary standards calibrated to the BCR-ABL WHO panel
• Clinically demonstrated limit of detection of <4.5-log reduction (0.0030%)
• Probe Check Control (PCC) are included in each Cartridge

Target Philadelphia chromosome(e13a2/b2a2 and e14a2/b3a2)

Specimen EDTA Whole Blood

Order information

Product	Cat No.	Storage temp.	Test/Kit
Xpert BCR-ABL Ultra	GXBCRABL-US-10	2 ~ 8 ℃	10T/Kit

This product is “For Professional”, “Disposable” and “in vitro diagnostic medical device”.
please refer to “Precautions for use” and “Instructions for use”.