Vietnam MOH registration 240002502/PCBB-HN

IVD Quantitative Prealbumin Test Kit

VN: Bộ IVD xét nghiệm định lượng Prealbumin

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Beckman Coulter, Inc.·Registered Sep 23, 2024

Registration details

Analysis ID: 240002502/PCBB-HN
Submission ID: 000.00.19.H26-240918-0007
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Beckman Coulter, Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: Beckman Coulter, Inc.
Authorized Representative: CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG

Technical details

Intended Use: PREALBUMIN: Prealbumin is an in vitro diagnostic medical device used by healthcare professionals to quantify prealbumin in human serum by turbidimetric immunoassay, using the Beckman Coulter AU/DxC AU automated analyzers. The measurement of prealbumin is used in the diagnostic support of malnutrition conditions. PREALBUMIN CALIBRATOR: Prealbumin Calibrator is a liquid human serum based calibrator used in conjunction with the Prealbumin OSR6175 reagent to quantify prealbumin, using the Beckman Coulter AU/DxC AU automated analyzers.

Dates and status

Registration Date: Sep 23, 2024

About this record

Access comprehensive regulatory information for IVD Quantitative Prealbumin Test Kit in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002502/PCBB-HN and manufactured by Beckman Coulter, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.

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.