Vietnam MOH registration 2403708ĐKLH/BYT-HTTB

MLH1 Protein Qualitative Test Kit

VN: Thuốc thử xét nghiệm định tính protein MLH1

Vietnam·Risk Class TBYT Loại C·VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody·Ventana Medical Systems, Inc.·Registered Nov 19, 2024

Registration details

Analysis ID: 2403708ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230724-0005
Product Type: VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody
Product Code: 09605584001

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 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

Registration Date: Nov 19, 2024

About this record

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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