Vietnam MOH registration 230000323/PCBB-BYT

ClDN18 Qualitative Protein Assay

VN: Thuốc thử xét nghiệm định tính protein Claudin 18 (CLDN18)

Vietnam·Risk Class TTBYT Loại B·VENTANA CLDN18 (43-14A) Assay·Ventana Medical Systems, Inc.·Registered Aug 08, 2023

Registration details

Analysis ID: 230000323/PCBB-BYT
Submission ID: 000.00.04.G18-230808-0002
Product Type: VENTANA CLDN18 (43-14A) Assay
Product Code: 08504148001

Company information

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

Technical details

Intended Use: VENTANA CLDN18 (43-14A) Assay is used to detect the protein Claudin 18 (CLDN18) on formalin-fixed, paraffin-embedded (FFPE) tumor tissue sections, stained on the BenchMark IHC/ISH. This product must be interpreted by a qualified pathologist in conjunction with histology, clinical information, and appropriate control material. This antibody is intended for in vitro diagnostic use (IVD).

Dates and status

Registration Date: Aug 08, 2023

About this record

Access comprehensive regulatory information for ClDN18 Qualitative Protein Assay 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 230000323/PCBB-BYT and manufactured by Ventana Medical Systems, Inc..

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