Vietnam MOH registration 2401182ĐKLH/BYT-HTTB

MLH1 protein qualitative test reagent

VN: Thuốc thử xét nghiệm định tính protein MLH1

Vietnam·Risk Class TTBYT Loại C·VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody·Ventana Medical Systems, Inc.·Registered Jul 22, 2024

Registration details

Analysis ID: 2401182ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231218-0020
Product Type: VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody
Product Code: 08033668001

Company information

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

Technical details

Intended Use: VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody (VENTANA anti-MLH1 (M1)) is used in the laboratory to detect the protein MLH1 by immunohistochemistry in formalin-fixed, paraffin-embedded (FFPE) tissue sections using optical microscopy. VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody is ready-to-use on the BenchMark IHC/ISH with OptiView DAB Detection Kit and related accessories. VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody is a component of the VENTANA MMR RxDx Panel and VENTANA MMR IHC Panel, which are listed in Table 1. Table 1. Name of the Test and Clinical Application: - VENTANA MMR RxDx Panel (MLH1, PMS2, MSH2 and MSH6): The VENTANA MMR RxDx Panel is indicated to support the identification of patients with mismatch repair deficient (dMMR) endometrial carcinoma who are candidates for treatment with JEMPERLI (dostarlimab), as per the product label. - VENTANA MMR IHC Panel (MLH1, PMS2, MSH2, MSH6 and BRAF V600E): The VENTANA MMR IHC Panel is indicated for the detection of mismatch repair deficient (dMMR) protein, which is a test to identify individuals at risk for Lynch syndrome in patients diagnosed with colorectal cancer (CRC), and, in combination with the BRAF V600E status, supports differentiation between sporadic colorectal cancer and colorectal cancer that may be due to Lynch syndrome when no MLH1 protein expression is observed. The results of this test must be interpreted by a qualified pathologist in conjunction with histology, relevant clinical information, and appropriate control samples. This product is intended for in vitro diagnostic use (IVD).

Dates and status

Registration Date: Jul 22, 2024

About this record

Access comprehensive regulatory information for MLH1 protein qualitative test reagent 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 2401182ĐKLH/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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