Vietnam MOH registration 240002764/PCBB-HN

IVD Marker for Rheumatoid Arthritis: CRP, ASO

VN: Cụm IVD dấu ấn bệnh viêm khớp: CRP, ASO

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Beckman Coulter, Inc.·Registered Oct 15, 2024

Registration details

Analysis ID: 240002764/PCBB-HN
Submission ID: 000.00.19.H26-241002-0033
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. CRP: CRP test is an in vitro diagnostic medical device used by medical specialists to quantify the concentration of C-Reactive Protein (CRP) in human serum and plasma by the turbidimetric immunoassay method, using the Beckman Coulter AU/DxC AU automated analyzers. The measurement of CRP is used in the support of diagnosis and monitoring of the inflammatory process. 2. ASO: ASO test is an in vitro diagnostic medical device used by medical specialists to quantify Anti-Streptolysin O (ASO) in human serum by the turbidimetric immunoassay method, using the Beckman Coulter AU/DxC AU automated analyzers. The measurement of ASO antibodies is used in the support of diagnosis of the condition of infection with group A Streptococcus previously.

Dates and status

Registration Date: Oct 15, 2024

About this record

Access comprehensive regulatory information for IVD Marker for Rheumatoid Arthritis: CRP, ASO 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 240002764/PCBB-HN and manufactured by Beckman Coulter, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.

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