Vietnam MOH registration 240002765/PCBB-HN

Drug Testing, Reference Standard for Quantitative Analysis of Total Protein

VN: Thuốc thử, chất hiệu chuẩn xét nghiệm định lượng protein toàn phần

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

Registration details

Analysis ID: 240002765/PCBB-HN
Submission ID: 000.00.19.H26-241002-0030
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: Urinary/CSF Protein Test is an in vitro diagnostic medical device used by healthcare professionals to quantify the total protein in urine and cerebrospinal fluid (CSF) of humans by the colorimetric method, using the Beckman Coulter AU/DxC AU automated analyzers. The measurement of total protein in urine is used in the diagnostic support of kidney disorder conditions. The measurement of total protein in cerebrospinal fluid (CSF) is used in the diagnostic support of central nervous system (CNS) disorder conditions.

Dates and status

Registration Date: Oct 15, 2024

About this record

Access comprehensive regulatory information for Drug Testing, Reference Standard for Quantitative Analysis of Total Protein 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 240002765/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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