Vietnam MOH registration 230003174/PCBB-HN

The IVD Cancer Marker Cluster: AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, CYFRA21-1, NSE, SCC

VN: Cụm IVD các dấu ấn ung thư: AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, CYFRA21-1, NSE, SCC

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Nov 30, 2023

Registration details

Analysis ID: 230003174/PCBB-HN
Submission ID: 000.00.19.H26-231128-0004
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Theo theo phụ lục
Manufacturer Country: Theo theo phụ lục

Technical details

Intended Use: The quantitative AFP test is used for the quantitative determination of alpha-fetoprotein (AFP) in human serum and plasma. Clinically, it is primarily used as a supportive diagnostic tool, a therapeutic effect and prognosis of primary liver cancer. Professional use only; The quantitative CA125 test is used for the quantitative determination of cancer antigen 125 (CA125) in human serum or plasma. Clinically, it is primarily used as a supportive diagnostic tool and monitoring treatment of ovarian cancer and other types of cancer. Professional use only; The quantitative CA15-3 test is used for the quantitative determination of cancer antigen 15-3 (CA15-3) in human serum equivalent. Clinically, it is primarily used to monitor the effectiveness of treatment and prognosis of breast cancer. Professional use only; The quantitative CA15-3 test is used for the quantitative determination of cancer antigen 15-3 (CA15-3) in human serum equivalent. Clinically, it is primarily used to monitor the effectiveness of treatment and prognosis of breast cancer. Professional use only; The quantitative CA19-9 test is used to determine the concentration of carbohydrate antigen 19-9 (CA19-9) in human serum or plasma in vitro. Clinically, it is primarily used as a supportive diagnostic tool and monitoring the effectiveness of treatment of cancer of the digestive tract, such as the pancreas. Professional use only; The quantitative CA72-4 test is used to determine the concentration of cancer antigen 72-4 (CA72-4) in human serum and plasma in vitro. Clinically, it is primarily used to monitor the effectiveness of treatment of solid tumors and to support the evaluation of the disease process or treatment effectiveness. Professional use only; The quantitative CEA (CLIA) test is used to determine the concentration of carcinoembryonic antigen (CEA) in human serum or plasma in vitro. Clinically, it is primarily used as a supportive diagnostic tool and monitoring the effectiveness of treatment and recurrence in patients with cancer. Professional use only; The quantitative CYFRA21-1 test is used to determine the concentration of the fragment in human serum and plasma in vitro. Clinically, it is primarily used to monitor the effectiveness of treatment and recurrence in patients with non-small cell lung cancer (NSCLC). Professional use only; The quantitative NSE test is used to determine the concentration of neuron-specific enolase (NSE) in human serum and plasma in vitro. Clinically, it is primarily used as a supportive diagnostic tool for small cell lung cancer (SCLC) and to differentiate it from non-small cell lung cancer (NSCLC). Professional use only; The quantitative SCC test is used to determine the concentration of squamous cell carcinoma antigen (SCC) in human serum, plasma and whole blood in vitro. Clinically, it is primarily used as a supportive diagnostic tool for cervical cancer and squamous cell carcinoma. Professional use only.

Dates and status

Registration Date: Nov 30, 2023

About this record

Access comprehensive regulatory information for The IVD Cancer Marker Cluster: AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, CYFRA21-1, NSE, SCC 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 230003174/PCBB-HN and manufactured by Theo theo phụ lục.

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