Vietnam MOH registration 240000670/PCBB-HCM

Calcitonin polypeptide qualitative test reagent

VN: Thuốc thử xét nghiệm định tính Calcitonin polypeptide

Vietnam·Risk Class TTBYT Loại B·anti-Calcitonin (SP17) Rabbit Monoclonal Primary Antibody·Cell Marque Corporation·Registered Apr 01, 2024

Registration details

Analysis ID: 240000670/PCBB-HCM
Submission ID: 000.00.19.H29-240320-0015
Product Type: anti-Calcitonin (SP17) Rabbit Monoclonal Primary Antibody
Product Code: 06586554001

Company information

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

Technical details

Intended Use: Calcitonin (SP17) Rabbit Monoclonal Primary Antibody is used in the laboratory to detect Calcitonin polypeptide on formalin-fixed, paraffin-embedded human tissue by immunohistochemistry (IHC) on the Benchmark IHC/ISH. This 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 01, 2024

About this record

Access comprehensive regulatory information for Calcitonin polypeptide qualitative test reagent 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 240000670/PCBB-HCM and manufactured by Cell Marque Corporation. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.