IVD Base Cluster: CRP, HAEMOGLOBIN A1c (HbA1C), FERRITIN (FERR), TRANSFERRITIN (TF), HDL-CHOLESTEROL (HDL), LDL-CHOLESTEROL (LDL), RHEUMATOID FACTOR (RF) - Vietnam Registration 230002393/PCBB-HCM
Access comprehensive regulatory information for IVD Base Cluster: CRP, HAEMOGLOBIN A1c (HbA1C), FERRITIN (FERR), TRANSFERRITIN (TF), HDL-CHOLESTEROL (HDL), LDL-CHOLESTEROL (LDL), RHEUMATOID FACTOR (RF) 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 230002393/PCBB-HCM and manufactured by Theo theo phụ lục.
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Device Details
Registration Details
230002393/PCBB-HCM
000.00.19.H29-231019-0011
Theo theo phụ lục
Theo phụ lục
Technical Details
The CRP test reagent is used to quantitatively determine the concentration of C-reactive protein (CRP) in serum or plasma. The CRP quantitative test calibration standard is used in clinical chemistry systems to calibrate the CRP quantitative test. The CRP quantitative test control material is used with the hsCRP test to control accuracy and to control reproducibility and is used in the quality control of CRP on clinical chemistry systems. The HbA1c test reagent is used to quantitatively determine the concentration of Hemoglobin A1c in whole blood. The HbA1c quantitative test calibration standard is used in the calibration of the HbA1c test. The HbA1c quantitative test control material is used in the quality control of HbA1c on clinical chemistry analyzers. The Ferritin (FERR) test reagent is a tool used to quantitatively determine the concentration of Ferritin in serum. The Transferrin (TF) test reagent is a tool used to quantitatively determine the concentration of Transferrin in serum. The CRP, FERRITIN, TRANSFERRIN, RF test calibration standard is used in the calibration of the CRP, FERRITIN, TRANSFERRIN, RF tests. The TRANSFERRIN, RF test control material is used in the quality control of serum on clinical chemistry analyzers and immunoassay analyzers. The HDL-CHOLESTEROL (HDL) test reagent is used to quantitatively determine the concentration of HDL Cholesterol in serum and plasma. The LDL-CHOLESTEROL (LDL) test reagent is used to quantitatively determine the concentration of LDL Cholesterol in serum and plasma. The LDL, HDL test calibration standard is used in the in vitro calibration of the HDL & LDL Cholesterol measurement method. The LDL-CHOLESTEROL (sLDL) test reagent is used to quantitatively determine the concentration of small, dense LDL cholesterol (sd-C) in serum or plasma of humans. The LDL-CHOLESTEROL (sLDL) test calibration standard is used in the calibration of the sLDL test. The LDL-CHOLESTEROL (sLDL) test control material is used in the quality control of the sLDL test. The HDL, ALB, T BIL, CREA, UA, UREA, TP, CHOL, GLUC, LAC, TRIGS, D BIL, MG, PHOS test control material is used to control accuracy. The HDL, LDL, CHOL, TRIGS test control material is used in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), Cholesterol and Triglyceride on clinical chemistry analyzers. The Rheumatoid Factor (RF) test reagent is a tool used to quantitatively determine the concentration of Rheumatoid Factors (RF) in serum
Dates and Status
Nov 01, 2023

