Vietnam MOH registration 240002873/PCBB-HN

IVD Protein Complex: α-1 Acidglycoprotein, β-2 Microglobulin

VN: Cụm IVD Các Protein Đặc thù khác: α-1 Acidglycoprotein, β-2 Microglobulin

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Beckman Coulter, Inc.·Registered Oct 24, 2024

Registration details

Analysis ID: 240002873/PCBB-HN
Submission ID: 000.00.19.H26-241015-0020
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: 1. α-1 Acidglycoprotein: The α-1 Acidglycoprotein test is an in vitro diagnostic medical device used by healthcare professionals to quantitate α-1 acidglycoprotein in human serum and plasma by turbidimetric immunoassay, using the Beckman Coulter AU/DxC AU automated analyzers. The measurement of α-1 acidglycoprotein is used in the diagnostic support of infection or acute inflammation. 2. β-2 Microglobulin: The β-2 Microglobulin test is an in vitro diagnostic medical device used by healthcare professionals to quantitate β-2 microglobulin in human serum and plasma by turbidimetric immunoassay, using the Beckman Coulter AU/DxC AU automated analyzers. The measurement of β-2 microglobulin is used in the diagnostic support of kidney disease or as a marker of change in the lymphocyte cell cycle.

Dates and status

Registration Date: Oct 24, 2024

About this record

Access comprehensive regulatory information for IVD Protein Complex: α-1 Acidglycoprotein, β-2 Microglobulin 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 240002873/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.