IVD Base Complex: AMMONIA (NH3), ETHANOL (EtOH), TRIGLYCERIDES (TRIGS), COPPER (CU), L-LACTATE (LAC), MICROALBUMIN (mALB), FRUCTOSAMINE (FRUC), IgE - Vietnam Registration 230002388/PCBB-HCM
Access comprehensive regulatory information for IVD Base Complex: AMMONIA (NH3), ETHANOL (EtOH), TRIGLYCERIDES (TRIGS), COPPER (CU), L-LACTATE (LAC), MICROALBUMIN (mALB), FRUCTOSAMINE (FRUC), IgE 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 230002388/PCBB-HCM and manufactured by Theo theo phụ lục.
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.
Device Details
Registration Details
230002388/PCBB-HCM
000.00.19.H29-231016-0010
Theo theo phụ lục
Theo phụ lục
Technical Details
Ammonia (NH3) Test Reagent for quantitative determination of Ammonia in blood serum. Ethanol (EtOH) Test Reagent for quantitative determination of ethanol in urine and blood serum of humans. The Ethanol (EtOH) Quantitative Test Control Reagent is used to calibrate and control the quality of the Randox Ethanol test, which is used to quantitatively determine ethanol in human urine. The Quantitative Ethanol (EtOH) Test Control Reagent is used to control the quality of the Randox Ethanol test and to ensure the accuracy and to detect systematic analytical errors on clinical biochemistry analyzers. The Quantitative Ammonia (NH3) and Ethanol (EtOH) Test Control Reagent is used to control the quality of the Ammonia and Ethanol tests and to ensure the accuracy and to detect systematic analytical errors on clinical biochemistry analyzers. Triglycerides (TRIGS) Test Reagent for quantitative determination of Triglycerides in blood serum in the test tube. Copper (Cu) Test Reagent for quantitative determination of Cu (Copper) concentration in blood serum and blood plasma. L-Lactate (LAC) Test Reagent for quantitative determination of L-Lactate concentration in blood serum. Microalbumin (mALB) Test Reagent for quantitative determination of Microalbumin concentration in urine. The Microalbumin (mALB) Quantitative Test Control Reagent is used to calibrate the Microalbumin test. Fructosamine (FRUC) Test Reagent for quantitative determination of glycated protein (fructosamine) concentration in blood serum or blood plasma of humans in the test tube. The Fructosamine (FRUC) Quantitative Test Control Reagent is used to calibrate the Randox Liquid Fructosamine test on clinical biochemistry analyzers. The Fructosamine (FRUC) Quantitative Test Control Reagent is used to control the quality of the Randox Liquid Fructosamine test on clinical biochemistry analyzers. IgE Test Reagent for quantitative determination of the concentration of globulin E (IgE) in blood serum or blood plasma of humans. The IgE Quantitative Test Control Reagent is used to calibrate the IgE test in a stable environment. The Quantitative IgE Test Control Reagent is used to calibrate the IgE test in a stable environment. The Quantitative HDL, ALB, T BIL, CREA, UA, UREA, TP, CHOL, GLUC, LAC, TRIGS, D BIL, MG, PHOS Test Control Reagent is used to control the accuracy. The Quantitative ALB, T BIL, CREA, UREA, UA, TP, GLUC, LAC, TRIGS, Cu, D BIL, PHOS, MG, ZN Test Control Reagent is used to calibrate the clinical biochemistry tests. The Quantitative UREA, UA, TP, GLUC, CREA, TP, mALB, Cu, PHOS, MG Test Control Reagent is used to control the quality of the urine analysis on clinical biochemistry analyzers. The Quantitative HDL, LDL, CHOL, TRIGS Test Control Reagent is used to control the quality of the Direct HDL, Direct LDL, Lipoprotein (a), Cholesterol and Triglyceride tests on clinical biochemistry analyzers.
Dates and Status
Nov 01, 2023

