Vietnam MOH registration 2401163ĐKLH/BYT-HTTB

HER2 Quantitative Antigen Assay Test Kit

VN: Thuốc thử xét nghiệm bán định lượng kháng nguyên HER2

Vietnam·Risk Class TTBYT Loại C·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody·Ventana Medical Systems, Inc.·Registered Jul 22, 2024

Registration details

Analysis ID: 2401163ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231024-0006
Product Type: PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
Product Code: 05278368001

Company information

Manufacturer: Ventana Medical Systems, Inc.
Manufacturer Country: UNITED STATES
Product Owner: Ventana Medical Systems, Inc.
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY HER2 (4B5)) of Ventana Medical Systems, Inc. (Ventana) is a rabbit monoclonal antibody used in the laboratory to detect the quantitative amount of HER2 antigen on normal tissue sections and formalin-fixed, paraffin-embedded cancer tissue sections, and subsequently stained on the BenchMark IHC/ISH. The test is indicated to support the evaluation of breast cancer patients who are being considered for treatment with Herceptin® (trastuzumab) or KADCYLA® (ado-trastuzumab emtansine). This product must be interpreted by a pathologist with combined expertise in histology and clinical information, and appropriate control material. The antibody is intended for in vitro diagnostic use (IVD). Note: All patients in the Herceptin clinical trials were selected using a clinical trial assay. No patients in these trials were selected using PATHWAY anti-HER-2/neu (4B5). PATHWAY anti-HER-2/neu (4B5) was compared to PATHWAY HER-2 (clone CB11) Primary Antibody on an independent test panel and yielded acceptable concordant results. The actual correlation of PATHWAY anti-HER-2/neu (4B5) to clinical outcomes has not been established.

Dates and status

Registration Date: Jul 22, 2024

About this record

Access comprehensive regulatory information for HER2 Quantitative Antigen Assay Test Kit 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 2401163ĐKLH/BYT-HTTB and manufactured by Ventana Medical Systems, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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