Taiwan FDA registration eb0231ae86ca1aba46fd819bc180fa18

Xpert BCR-ABL Ultra

TW: 艾斯柏特 BCR-ABL 高敏檢測試劑組

Taiwan·Risk Class 3·MD·CEPHEID·Registered Nov 27, 2018 – Nov 27, 2023Expired

Registration details

Analysis ID: eb0231ae86ca1aba46fd819bc180fa18
License Form: Ministry of Health Medical Device Import No. 031804
Customs Code: DHA05603180403

Company information

Manufacturer: CEPHEID
Manufacturer Country: United States
Authorized Representative: PROGRESSIVE GROUP INC.

Product details

Intended Use: 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.
Product Type (Level 1): B Hematology and pathology devices
Product Type (Level 2): B4020 Analyze specific reagents
Import Information: Imported from abroad

Dates and status

Registration Date: Nov 27, 2018
Expiry Date: Nov 27, 2023

About this record

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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