Vietnam MOH registration 230001278/PCBB-HN

IVD Enzyme Complex: Alkaline Phosphatase, α-Amylase, Gamma-GT, GPT (ALT), GOT (AST), LDH, Lipase

VN: Cụm IVD enzyme: Alkaline phosphate, α-Amylase, Gamma-GT, GPT (ALT), GOT (AST), LDH, Lipase

Theo phụ lục

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Jun 08, 2023

Registration details

Analysis ID: 230001278/PCBB-HN
Submission ID: 000.00.19.H26-230605-0009
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Theo theo phụ lục
Manufacturer Country: Theo theo phụ lục

Technical details

Intended Use: Alkaline phosphate: Used in in vitro diagnostic tests to quantify alkaline phosphatase (ALP) in serum, plasma. Amylase (α-Amylase): Used in in vitro diagnostic tests to quantify α-Amylase in serum, plasma. Gamma-GT: Used in in vitro diagnostic tests to quantify γ-glutamyl transferase in serum, plasma. GPT (ALT): Used in in vitro diagnostic tests to quantify alanine aminotransferase (ALT) in serum, plasma. GOT (AST): Used in in vitro diagnostic tests to quantify aspartate aminotransferase (AST) in serum, plasma. LDH: Used in in vitro diagnostic tests to quantify Lactat dehydrogenase (LDH) in serum, plasma. Lipase: Used in in vitro diagnostic tests to quantify Lipase in serum, plasma.

Dates and status

Registration Date: Jun 08, 2023

About this record

Access comprehensive regulatory information for IVD Enzyme Complex: Alkaline Phosphatase, α-Amylase, Gamma-GT, GPT (ALT), GOT (AST), LDH, Lipase 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 230001278/PCBB-HN and manufactured by Theo theo phụ lục.

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