Vietnam MOH registration 220003773/PCBB-HCM

Qualitative glycoprotein Ep-CAM Test Kit

VN: Thuốc thử xét nghiệm định tính glycoprotein Ep-CAM

Vietnam·Risk Class TTBYT Loại B·Ep-CAM/Epithelial Specific Antigen (Ber-EP4) Mouse Monoclonal Antibody·Cell Marque Corporation·Registered Nov 25, 2022

Registration details

Analysis ID: 220003773/PCBB-HCM
Submission ID: 000.00.19.H29-221122-0038
Product Type: Ep-CAM/Epithelial Specific Antigen (Ber-EP4) Mouse Monoclonal Antibody
Product Code: 05435676001

Company information

Manufacturer: Cell Marque Corporation

Technical details

Intended Use: Ep-CAM/Epithelial Specific Antigen (Ber-EP4) Mouse Monoclonal Primary Antibody is used in the laboratory to detect the glycoprotein Ep-CAM on formalin-fixed, paraffin-embedded human tissue by immunohistochemistry (IHC) on the Benchmark IHC/ISH. This product must be interpreted by a qualified pathologist in conjunction with histology testing, relevant clinical information, and appropriate control material. The antibody is intended for in vitro diagnostic use (IVD).

Dates and status

Registration Date: Nov 25, 2022

About this record

Access comprehensive regulatory information for Qualitative glycoprotein Ep-CAM Test Kit in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 220003773/PCBB-HCM and manufactured by Cell Marque Corporation.

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