Vietnam MOH registration 240000748/PCBB-HCM

Qualitative Protein Cytokeratin 19

VN: Thuốc thử xét nghiệm định tính protein Cytokeratin 19

Vietnam·Risk Class TTBYT Loại B·Cytokeratin 19 (A53-B/A2.26) Mouse Monoclonal Antibody·Cell Marque Corporation·Registered Apr 10, 2024

Registration details

Analysis ID: 240000748/PCBB-HCM
Submission ID: 000.00.19.H29-240405-0023
Product Type: Cytokeratin 19 (A53-B/A2.26) Mouse Monoclonal Antibody
Product Code: 05269440001

Company information

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

Technical details

Intended Use: Cytokeratin 19 (A53-B/A2.26) Mouse Monoclonal Antibody is used in the laboratory to detect Cytokeratin 19 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 (positive control) samples. 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 19 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 240000748/PCBB-HCM and manufactured by Cell Marque Corporation. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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