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IVD Base Cluster: DIRECT BILIRUBIN (D BIL), Non-Esterified Fatty Acids (NEFA), TOTAL BILE ACIDS (TBA), ZINC (Zn), MAGNESIUM (Mg), INORGANIC PHOSPHOROUS (PHOS), CYSTATIN C (CYSC), CYTOKINE (CTK) - Vietnam Registration 230002392/PCBB-HCM

Access comprehensive regulatory information for IVD Base Cluster: DIRECT BILIRUBIN (D BIL), Non-Esterified Fatty Acids (NEFA), TOTAL BILE ACIDS (TBA), ZINC (Zn), MAGNESIUM (Mg), INORGANIC PHOSPHOROUS (PHOS), CYSTATIN C (CYSC), CYTOKINE (CTK) 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 230002392/PCBB-HCM and manufactured by Theo theo phụ lục.

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230002392/PCBB-HCM
Registration Details
Vietnam MOH Registration: 230002392/PCBB-HCM
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Device Details

IVD Base Cluster: DIRECT BILIRUBIN (D BIL), Non-Esterified Fatty Acids (NEFA), TOTAL BILE ACIDS (TBA), ZINC (Zn), MAGNESIUM (Mg), INORGANIC PHOSPHOROUS (PHOS), CYSTATIN C (CYSC), CYTOKINE (CTK)
VN: Cụm IVD Chất nền: DIRECT BILIRUBIN (D BIL), Non-Esterified Fatty Acids (NEFA), TOTAL BILE ACIDS (TBA), ZINC (Zn), MAGNESIUM (Mg), INORGANIC PHOSPHOROUS (PHOS), CYSTATIN C (CYSC), CYTOKINE (CTK)
Risk Class TTBYT Loại B

Registration Details

230002392/PCBB-HCM

000.00.19.H29-231017-0011

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Technical Details

DIRECT BILIRUBIN (D BIL) test quantitatively determines the concentration of direct bilirubin in serum and plasma. Non-Esterified Fatty Acids (NEFA) test quantitatively determines the concentration of non-esterified fatty acids (NEFA) in serum and plasma. TOTAL BILE ACIDS (TBA) test quantitatively determines the concentration of total bile acids in serum and plasma. ZINC (Zn) test quantitatively determines the concentration of zinc in serum, plasma and urine. IVD for quantitative determination of ZINC (Zn) quantitatively determines the concentration of zinc in serum, plasma and urine. MAGNESIUM (Mg) test is a tool for determining the concentration of magnesium in serum and urine. INORGANIC PHOSPHOROUS (PHOS) test is a tool for quantitatively determining the concentration of inorganic phosphorous in serum, plasma and urine. CYSTATIN C (CYSC) test is used to quantitatively determine the concentration of cystatin C in serum and plasma. CYSTATIN C (CYSC) calibrator is used to calibrate cystatin C in serum and plasma. CYSTATIN C (CYSC) control material is used to control the concentration of cystatin C in serum and plasma. CYTOKINE (CTK) test is used to quantitatively determine the concentration of multiple cytokine-related immune assays (multiplex) from a single sample. Cytokine (CTK) control material is used as a quality control material that has been analyzed in the regular monitoring of accuracy and reproducibility for the analytes. Control material for quantitative determination of HDL, ALB, T BIL, CREA, UA, UREA, TP, CHOL, GLUC, LAC, TRIGS, D BIL, MG, PHOS, BILE ACIDS is used to control accuracy. ALB, T BIL, CREA, UREA, UA, TP, GLUC, LAC, TRIGS, Cu, D BIL, PHOS, MG, ZN calibrator is used to calibrate clinical chemistry assays. Control material for quantitative determination of UREA, UA, TP, GLUC, CREA, TP, mALB, Cu, PHOS, MG is used for the diagnosis and quality control of urine on clinical chemistry analyzers

Dates and Status

Nov 01, 2023