Vietnam MOH registration 240000033/PCBB-HP

IVD Lipid Peroxidation Complex

VN: Cụm IVD Mỡ máu

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Shanghai Kehua Bio-Engineering Co., Ltd.·Registered Nov 21, 2024

Registration details

Analysis ID: 240000033/PCBB-HP
Submission ID: 000.00.18.H24-241028-0002
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Shanghai Kehua Bio-Engineering Co., Ltd.
Manufacturer Country: Theo theo phụ lục
Product Owner: Shanghai Kehua Bio-Engineering Co., Ltd.
Authorized Representative: CÔNG TY TNHH CÔNG NGHỆ TIANLONG VIỆT NAM

Technical details

Intended Use: Apolipoprotein A1 Kit (Immunoturbidimetric Assay) is an in vitro diagnostic test to quantify Apolipoprotein A1 (APO A1) in human serum and plasma on a clinical chemistry analyzer to assist in clinical diagnosis. Apolipoprotein B Kit (Immunoturbidimetric Assay) is an in vitro diagnostic test to quantify Apolipoprotein B (ApoB) in human serum and plasma on a clinical chemistry analyzer to assist in clinical diagnosis. Apolipoprotein E (Latex Immunoturbidimetric Method) is an in vitro diagnostic test to determine the concentration of Apolipoprotein E (ApoE) in human serum and plasma as a clinical diagnostic aid. Lipoprotein (a) Test Kit (Latex Immunoturbidimetric Method) is an in vitro diagnostic test to determine the concentration of Lipoprotein (a) in human serum and plasma as a clinical diagnostic aid. Lipoprotein-associated Phospholipase A2 Kit (Latex Immunoturbidimetric Method) is an in vitro diagnostic test to determine the concentration of lipoprotein-associated phospholipase A2 in human serum or plasma on a clinical chemistry analyzer to assist in clinical diagnosis.

Dates and status

Registration Date: Nov 21, 2024

About this record

Access comprehensive regulatory information for IVD Lipid Peroxidation Complex 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 240000033/PCBB-HP and manufactured by Shanghai Kehua Bio-Engineering Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH CÔNG NGHỆ TIANLONG VIỆT NAM.

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