Xpert BCR-ABL Ultra - Taiwan Registration eb0231ae86ca1aba46fd819bc180fa18
Access comprehensive regulatory information for Xpert BCR-ABL Ultra in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number eb0231ae86ca1aba46fd819bc180fa18 and manufactured by CEPHEID. The authorized representative in Taiwan is PROGRESSIVE GROUP INC..
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Device Details
Registration Details
eb0231ae86ca1aba46fd819bc180fa18
Ministry of Health Medical Device Import No. 031804
DHA05603180403
Product Details
This product is used with the GeneXpert Instrument System (DH Medical Device Transfusion No. 006789) to quantify BCR-ABL1 chromosomal translocation MRNA transcripts (type e/3a2/b2a2 or e14a2/b3a2) and ABL1 endogenous control MRNA transcripts for the detection of peripheral blood samples from patients with previously diagnosed chronic myeloid leukemia (CML). This product does not report specific types of BCR-ABL1 MRNA transcripts. This product is used to assist in monitoring BCR-ABL1 MRNA transcript content in peripheral blood samples of patients diagnosed with CML.
B Hematology and pathology devices
B4020 Analyze specific reagents
Imported from abroad
Dates and Status
Nov 27, 2018
Nov 27, 2023