IVD Base Compound - Vietnam Registration 230001481/PCBB-HN

Access comprehensive regulatory information for IVD Base Compound 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 230001481/PCBB-HN and manufactured by Theo theo phụ lục.

This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including Zybio Inc., Shanghai Kehua Bio-Engineering Co., Ltd., and 3 recent registrations in the same category. 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.

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230001481/PCBB-HN

Registration Details

Vietnam MOH Registration: 230001481/PCBB-HN

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Device Details

IVD Base Compound

VN: Cụm IVD Chất nền

Risk Class TTBYT Loại B

Registration Details

Analysis ID

230001481/PCBB-HN

Submission ID

000.00.19.H26-230628-0018

Product Type

Theo theo phụ lục

Product Code

Theo phụ lục

Technical Details

Intended Use

ALBUMIN: Used in in vitro diagnostic tests to quantify albumin in human serum or plasma TOTAL BILIRUBIN: Used in in vitro diagnostic tests to quantify total bilirubin in human serum or plasma DIRECT BILIRUBIN: Used in in vitro diagnostic tests to quantify direct bilirubin in human serum or plasma BILIRUBIN T&D: Used in in vitro diagnostic tests to quantify total and direct bilirubin in human serum or plasma CHOLESTEROL/ CHOLESTEROL –LQ / CHOLESTEROL-Free: Used in in vitro diagnostic tests to quantify cholesterol in human serum or plasma LDLc –D: Used in in vitro diagnostic tests to quantify LDL cholesterol in human serum or plasma HDLc –D/ HDLc –P/ HDLc -D. Direct: Used in in vitro diagnostic tests to quantify HDLc in human serum or plasma CHOLINESTERASE/ CHOLINESTERASE-LQ: Used in in vitro diagnostic tests to quantify cholineesterase in human serum or plasma CREATININE –J/ CREATININE –Je/ CREATININE –TR: Used in in vitro diagnostic tests to quantify creatinine in human serum or plasma FRUCTOSAMINE: Used in in vitro diagnostic tests to quantify fructosamine in human serum or plasma GLUCOSE/ GLUCOSE–LQ/ GLUCOSE –HK: Used in in vitro diagnostic tests to quantify glucose in human serum or plasma TRIGLYCERIDES / TRIGLYCERIDES –LQ: Used in in vitro diagnostic tests to quantify triglycerides in human serum or plasma UREA 37/ UREA B/ UREA UV/ UREA LQ: Used in in vitro diagnostic tests to quantify urea in human serum or plasma URIC ACID/ URIC ACID LQ: Used in in vitro diagnostic tests to quantify uric acid in human serum or plasma ZINC: Used in in vitro diagnostic tests to quantify zinc in human serum or plasma TOTAL BILE ACIDS: Used in in vitro diagnostic tests to quantify total bile acids in human serum or plasma TOTAL PROTEIN: Used in in vitro diagnostic tests to quantify total protein in human serum or plasma U&CSF TOTAL PROTEINS: Used in in vitro diagnostic tests to quantify total protein in urine and cerebrospinal fluid TOTAL BILE ACIDS CONTROL: Used as a quality control reagent for the quantification of total bile acids TOTAL BILE ACIDS CALIBRATOR: Used as a calibrator for the quantification of total bile acids BILIRUBIN CAL: Used as a calibrator for the quantification of bilirubin HDL/LDL CAL: Used as a calibrator for the quantification of HDL/LDL