Vietnam MOH registration 2402221ĐKLH/BYT-HTTB

Quantitative Polymerase Chain Reaction (PCR) Assay for the Wilms' Tumor (WT) Gene

VN: Bộ xét nghiệm định lượng bản phiên mã gen khối u Wilm (WT)

Vietnam·Risk Class TTBYT Loại C·ipsogen® WT1 ProfileQuant® Kit·Veracyte SAS·Registered Aug 27, 2024

Registration details

Analysis ID: 2402221ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-200419-0003
Product Type: ipsogen® WT1 ProfileQuant® Kit
Product Code: 676923

Company information

Manufacturer: Veracyte SAS
Manufacturer Country: FRANCE
Authorized Representative: CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG

Technical details

Intended Use: The Ipsogen WT1 ProfileQuant Kit is used to quantify the mRNA of the Wilms' tumor (WT) gene from the total RNA isolated from patients with acute myeloid leukemia (AML). The results are used to support early treatment response monitoring and minimal residual disease (MRD) monitoring

Dates and status

Registration Date: Aug 27, 2024

About this record

Access comprehensive regulatory information for Quantitative Polymerase Chain Reaction (PCR) Assay for the Wilms' Tumor (WT) Gene in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2402221ĐKLH/BYT-HTTB and manufactured by Veracyte SAS. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG.

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