Vietnam MOH registration 240000747/PCBB-HCM

Qualitative Protein Cytokeratin 5 Test Kit

VN: Thuốc thử xét nghiệm định tính protein Cytokeratin 5

Vietnam·Risk Class TTBYT Loại B·Cytokeratin 5 (SP27) Rabbit Monoclonal Primary Antibody·Cell Marque Corporation·Registered Apr 10, 2024

Registration details

Analysis ID: 240000747/PCBB-HCM
Submission ID: 000.00.19.H29-240405-0004
Product Type: Cytokeratin 5 (SP27) Rabbit Monoclonal Primary Antibody
Product Code: 07292821001

Company information

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

Technical details

Intended Use: Cytokeratin 5 (SP27) Rabbit Monoclonal Primary Antibody is used in the laboratory to detect Cytokeratin 5 protein on formalin-fixed, paraffin-embedded human tissue sections by immunohistochemistry (IHC) on the Benchmark IHC/ISH instrument. This product must be interpreted by a qualified pathologist in conjunction with histology testing, 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 10, 2024

About this record

Access comprehensive regulatory information for Qualitative Protein Cytokeratin 5 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 240000747/PCBB-HCM and manufactured by Cell Marque Corporation. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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