Vietnam MOH registration 240001789/PCBB-HCM

The IVD Base: Albumin; total bilirubin; direct bilirubin; Cholesterol; creatinine; glucose; protein; urea; uric acid; cholesterol lipoprotein; triglyceride

VN: Cụm IVD chất nền: Albumin; bilirubin toàn phần; bilirubin trực tiếp; Cholesterol; creatinine; glucose; protein; urea; acid uric; cholesterol lipoprotein ; triglyceride

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Meril Diagnostics Pvt. Ltd·Registered Aug 14, 2024

Registration details

Analysis ID: 240001789/PCBB-HCM
Submission ID: 000.00.19.H29-240317-0002
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Meril Diagnostics Pvt. Ltd
Manufacturer Country: Theo theo phụ lục
Product Owner: Meril Diagnostics Pvt. Ltd
Authorized Representative: CÔNG TY TNHH MERIL (VIỆT NAM)

Technical details

Intended Use: Albumin Kit AutoQuant is a reagent used to determine the concentration of albumin in human serum or plasma on the AutoQuant 400i/ 400 Supremus/ 400 biochemical analyzer. Bilirubin Total Kit AutoQuant is a reagent used to determine the concentration of total bilirubin in human serum or plasma on the AutoQuant 400i/ 400 Supremus/ 400 biochemical analyzer. Bilirubin Direct Kit AutoQuant is a reagent used to determine the concentration of direct bilirubin in human serum or plasma on the AutoQuant 400i/ 400 Supremus/ 400 biochemical analyzer. Cholesterol Kit AutoQuant is a reagent used to determine the concentration of cholesterol in human serum or plasma on the AutoQuant 400i/ 400 Supremus/ 400 biochemical analyzer. Creatinine Kit AutoQuant is a reagent used to determine the concentration of creatinine in human serum, plasma and urine on the AutoQuant 400i/ 400 Supremus/ 400 biochemical analyzer. Glucose Kit AutoQuant is a reagent used to determine the concentration of glucose in human serum or plasma on the AutoQuant 400i/ 400 Supremus/ 400 biochemical analyzer. Total Protein Kit AutoQuant is a reagent used to determine the concentration of protein in human serum or plasma on the AutoQuant 400i/ 400 Supremus/ 400 biochemical analyzer. Urea (BUN) Kit AutoQuant is a reagent used to determine the concentration of urea (BUN) in human serum and urine on the AutoQuant 400i/ 400 Supremus/ 400 biochemical analyzer. Uric Acid Kit AutoQuant is a reagent used to determine the concentration of uric acid in human serum or plasma and urine on the AutoQuant 400i/ 400 Supremus/ 400 biochemical analyzer. HDL Cholesterol (Direct) Kit AutoQuant is a reagent used to determine the concentration of high-density lipoprotein cholesterol (HDL-C) in human serum or plasma on the AutoQuant 400i/ 400 Supremus/ 400 biochemical analyzer. LDL Cholesterol (Direct) Kit AutoQuant is a reagent used to determine the concentration of low-density lipoprotein cholesterol (LDL-C) in human serum or plasma on the AutoQuant 400i/ 400 Supremus/ 400 biochemical analyzer. Micro Albumin Kit AutoQuant is a reagent used to determine the concentration of microalbumin in human urine by immunodiffusion turbidimetry on the AutoQuant 400i/ 400 Supremus/ 400 biochemical analyzer. Microprotein Kit AutoQuant is a reagent used to determine the concentration of protein in human urine and cerebrospinal fluid on the AutoQuant 400i/ 400 Supremus/ 400 biochemical analyzer. Triglyceride Kit AutoQuant is a reagent used to determine the concentration of triglycerides in human serum or plasma on the AutoQuant 400i/ 400 Supremus/ 400 biochemical analyzer.

Dates and status

Registration Date: Aug 14, 2024

About this record

Access comprehensive regulatory information for The IVD Base: Albumin; total bilirubin; direct bilirubin; Cholesterol; creatinine; glucose; protein; urea; uric acid; cholesterol lipoprotein; triglyceride 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 240001789/PCBB-HCM and manufactured by Meril Diagnostics Pvt. Ltd. The authorized representative in Vietnam is CÔNG TY TNHH MERIL (VIỆT NAM).

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.