Vietnam MOH registration 240000719/PCBB-HCM

Qualitative protein CA19-9 test

VN: Thuốc thử xét nghiệm định tính protein CA19-9

Vietnam·Risk Class TTBYT Loại B·CA19-9 (121SLE) Mouse Monoclonal Antibody·Cell Marque Corporation·Registered Apr 04, 2024

Registration details

Analysis ID: 240000719/PCBB-HCM
Submission ID: 000.00.19.H29-240328-0011
Product Type: CA19-9 (121SLE) Mouse Monoclonal Antibody
Product Code: 05267242001

Company information

Manufacturer: Cell Marque Corporation
Product Owner: Cell Marque Corporation
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: CA19-9 (121SLE) Mouse Monoclonal Antibody is used in the laboratory to detect the CA19-9 protein on formalin-fixed, paraffin-embedded human tissue sections by immunohistochemistry (IHC) on the Benchmark IHC/ISH instrument. The product must be interpreted by a qualified pathologist in conjunction with histology, relevant clinical information, and appropriate control material (positive control). This antibody is intended for in vitro diagnostic use (IVD).

Dates and status

Registration Date: Apr 04, 2024

About this record

Access comprehensive regulatory information for Qualitative protein CA19-9 test 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 240000719/PCBB-HCM and manufactured by Cell Marque Corporation. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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