Vietnam MOH registration 240000882/PCBB-HCM

Qualitative Protein CA 125 Test

VN: Thuốc thử xét nghiệm định tính protein CA 125

Vietnam·Risk Class TTBYT Loại B·CA-125 (OC125) Mouse Monoclonal Antibody·Cell Marque Corporation·Registered Apr 26, 2024

Registration details

Analysis ID: 240000882/PCBB-HCM
Submission ID: 000.00.19.H29-240410-0029
Product Type: CA-125 (OC125) Mouse Monoclonal Antibody
Product Code: 05267269001

Company information

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

Technical details

Intended Use: CA-125 (OC125) Mouse Monoclonal Primary Antibody is used in the laboratory to detect the CA 125 protein on formalin-fixed, paraffin-embedded human tissue sections, and is quantitatively assessed by immunohistochemistry (IHC) on the BenchMark IHC/ISH instrument. This product must be interpreted by a qualified pathologist in conjunction with histology, clinical information, and appropriate control material (positive control). This antibody is intended for in vitro diagnostic use (IVD).

Dates and status

Registration Date: Apr 26, 2024

About this record

Access comprehensive regulatory information for Qualitative Protein CA 125 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 240000882/PCBB-HCM and manufactured by Cell Marque Corporation. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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