Vietnam MOH registration 240002036/PCBB-HN

IVD Enzymes Cluster: Alkaline Phosphatase; Lactate Acid

VN: Cụm IVD Enzymes: Alkaline Phosphatase; Lactate Acid

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Archem Sağlık Sanayi ve Tic. A.Ş·Registered Aug 13, 2024

Registration details

Analysis ID: 240002036/PCBB-HN
Submission ID: 000.00.19.H26-240624-0015
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Archem Sağlık Sanayi ve Tic. A.Ş
Manufacturer Country: Theo theo phụ lục
Product Owner: Archem Sağlık Sanayi ve Tic. A.Ş
Authorized Representative: CÔNG TY TNHH THIẾT BỊ CÔNG NGHỆ NAM LONG

Technical details

Intended Use: The Alkaline Phosphatase (ALP) quantitative test is used to determine the concentration of Alkaline Phosphatase (ALP) in human blood serum. The Lactate Acid quantitative test is applied to determine the concentration of lactate in blood serum and brain tissue.

Dates and status

Registration Date: Aug 13, 2024

About this record

Access comprehensive regulatory information for IVD Enzymes Cluster: Alkaline Phosphatase; Lactate Acid 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 240002036/PCBB-HN and manufactured by Archem Sağlık Sanayi ve Tic. A.Ş. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ CÔNG NGHỆ NAM LONG.

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