Vietnam MOH registration 230000315/PCBB-BYT

Qualitative protein mutation test for the Epidermal Growth Factor Receptor (EGFR) L858R

VN: Thuốc thử xét nghiệm định tính protein đột biến của thụ thể yếu tố tăng trưởng biểu mô EGFR L858R

Vietnam·Risk Class TTBYT Loại B·anti-EGFR L858R (SP125) Rabbit Monoclonal Primary Antibody·Ventana Medical Systems, Inc.·Registered Jul 26, 2023

Registration details

Analysis ID: 230000315/PCBB-BYT
Submission ID: 000.00.04.G18-230726-0008
Product Type: anti-EGFR L858R (SP125) Rabbit Monoclonal Primary Antibody
Product Code: 06521924001

Company information

Manufacturer: Ventana Medical Systems, Inc.
Manufacturer Country: Tucson AZ 85755

Technical details

Intended Use: Anti-EGFR L858R (SP125) Rabbit Monoclonal Primary Antibody (anti-EGFR L858R (SP125)) is an immunostaining reagent that binds to the membrane and/or cytoplasm and can be used to support the determination of the protein variant of the epidermal growth factor receptor, EGFR L858R. This antibody is used to perform immunohistochemical staining on formalin-fixed, paraffin-embedded tissue sections. The test result must be interpreted by a qualified histopathologist in combination with histological examination, relevant clinical information, and appropriate positive control material. This antibody is intended for in vitro diagnostic use (IVD).

Dates and status

Registration Date: Jul 26, 2023

About this record

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