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MLH1 Protein Qualitative Test Kit - Vietnam Registration 2403708ĐKLH/BYT-HTTB

Access comprehensive regulatory information for MLH1 Protein Qualitative Test Kit in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403708ĐKLH/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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2403708ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2403708ĐKLH/BYT-HTTB
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Device Details

MLH1 Protein Qualitative Test Kit
VN: Thuốc thử xét nghiệm định tính protein MLH1
Risk Class TBYT Loại C

Registration Details

2403708ĐKLH/BYT-HTTB

000.00.04.G18-230724-0005

VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody

09605584001

Company Information

UNITED STATES

Technical Details

VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody (VENTANA anti-MLH1 (M1)) is used to detect the presence of the MLH1 protein in formalin-fixed, paraffin-embedded tissue sections. The VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody is available as a ready-to-use reagent on the BenchMark IHC/ISH platform, along with the OptiView DAB IHC Detection Kit and supporting reagents. VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody is a component of the VENTANA MMR IHC Panel (the VENTANA MMR Histology Immunoassay Panel), which includes VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP93) Rabbit Monoclonal Primary Antibody, and VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody. The VENTANA MMR IHC Panel is indicated for the detection of mismatch repair deficient protein, a test to identify individuals at risk for Lynch syndrome in patients diagnosed with colorectal cancer (CRC), and in combination with BRAF V600E status, aids in differentiating between sporadic colorectal cancer and colorectal cancer that may be due to Lynch syndrome when MLH1 protein expression is absent. This product must be interpreted by a qualified pathologist in conjunction with histology testing, relevant clinical information, and appropriate control material (positive control). This antibody is intended for in vitro diagnostic use (IVD).

Dates and Status

Nov 19, 2024