The IVD Base Cluster: HDL-C, LDL-C, CHO, TG, CRE, UREA, UA, TP, GLU, DB, TB, UP, LAC, CYSC, ZN - Vietnam Registration 240002465/PCBB-HN
Access comprehensive regulatory information for The IVD Base Cluster: HDL-C, LDL-C, CHO, TG, CRE, UREA, UA, TP, GLU, DB, TB, UP, LAC, CYSC, ZN 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 240002465/PCBB-HN and manufactured by BEIJING STRONG BIOTECHNOLOGIES, INC.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ CÔNG NGHỆ HKT.
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Device Details
Registration Details
240002465/PCBB-HN
000.00.19.H26-240820-0021
Theo theo phụ lục
Theo phụ lục
Technical Details
- High Density Lipoprotein Cholesterol (HDL-C) Test Reagent: Used in in vitro diagnosis to quantify the concentration of HDL-C in serum or plasma of humans. - HDL-C Quantification Test Calibration Standard: This is the calibration standard of the HDL-C quantification test kit, intended for in vitro diagnosis only. - Low-Density Lipoprotein Cholesterol (LDL-C) Test Reagent: Used in in vitro diagnosis to quantify the concentration of LDL-C in serum or plasma of humans. - LDL-C Quantification Test Calibration Standard: This is the calibration standard of the LDL-C quantification test kit, intended for in vitro diagnosis only. - Creatinine (CRE) Test Reagent: Used in in vitro diagnosis to quantify the concentration of creatinine in serum, plasma, or urine. - Total Cholesterol (CHO) Test Reagent: Used in in vitro diagnosis to quantify the concentration of cholesterol in serum or plasma. - Triglyceride (TG) Test Reagent: Used in in vitro diagnosis to quantify the concentration of triglycerides in serum. _ Direct Bilirubin (DBIL) Test Reagent: Used in in vitro diagnosis to quantify the concentration of direct bilirubin in serum or plasma. - Total Bilirubin (TBIL) Test Reagent: Used in in vitro diagnosis to quantify the concentration of total bilirubin in serum or plasma. - Glucose (GLU) Test Reagent: Used in in vitro diagnosis to quantify the concentration of glucose in serum. - Total Protein (TP) Test Reagent: Used in in vitro diagnosis to quantify the concentration of total protein in serum or plasma. - Uric Acid (UA) Test Reagent: Used in in vitro diagnosis to quantify the concentration of uric acid in serum, plasma, or urine. - Urea (UREA) Test Reagent: Used in in vitro diagnosis to quantify the concentration of urea in serum, plasma, or urine. - Cystatin C (CYS-C) Test Reagent: Used in in vitro diagnosis to quantify the concentration of Cystatin C in serum or plasma. - CYS-C Quantification Test Calibration Standard: This is the calibration standard of the CYS-C quantification test kit, intended for in vitro diagnosis only. - CYS-C Quantification Test Control Material: This is the control material of the CYS-C quantification test kit, intended for in vitro diagnosis only - Lactate (LAC) Test Reagent: Used in in vitro diagnosis to quantify the concentration of lactate in serum or plasma. - LAC Quantification Test Calibration Standard: This is the calibration standard of the LAC quantification test kit, intended for in vitro diagnosis only. - LAC Quantification Test Control Material: This is the control material of the LAC quantification test kit, intended for in vitro diagnosis only - Total Protein in Cerebrospinal Fluid/Urinary Tract (CFS/UP) Test Reagent: Used in in vitro diagnosis to quantify the concentration of total protein in urine or cerebrospinal fluid. - CFS/UP Quantification Test Calibration Standard: This is the calibration standard of the CFS/UP quantification test kit, intended for in vitro diagnosis only. - CFS/UP Quantification Test Control Material: This is the control material of the CFS/UP quantification test kit, intended for in vitro diagnosis only - Zinc (Zn) Test Reagent: Used in in vitro diagnosis to quantify the concentration of zinc in serum.
Dates and Status
Sep 18, 2024

