IVD Cancer Marker Cluster
Vietnam·Risk Class TTBYT Loại B·PSA, AFP, CA 125, CA 15-3, CA19-9·Nanjing Norman Biological techlonogy Co., Ltd·Registered Jan 24, 2024- Analysis ID
- 240000196/PCBB-HN
- Submission ID
- 000.00.19.H26-240118-0013
- Product Type
- PSA, AFP, CA 125, CA 15-3, CA19-9
- Product Code
- Theo phụ lục
- Manufacturer
- Nanjing Norman Biological techlonogy Co., Ltd
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Nanjing Norman Biological techlonogy Co., Ltd
- Authorized Representative
- CÔNG TY TNHH KỸ THUẬT THIẾT BỊ THIÊN PHÚC
- Intended Use
- 1. PSA Fast Test Kit (Immunofluorescence Assay): The PSA Fast Test Kit (Immunofluorescence Assay) (a full-prostate-specific antigen) is designated to determine the concentration of tPSA in vitro in human serum and plasma samples. It can be used to support the diagnosis and management of prostate cancer patients. 2.AFP Fast Test Kit (Immunofluorescence Assay): The AFP Fast Test Kit (Immunofluorescence Assay) is designated to determine the concentration of AFP in human serum or plasma samples. The test can be used to support the diagnosis and management of patients with liver cancer or cancer of the ovary or testis, and also to monitor the health of people with cirrhosis or hepatitis. 3. The quantitative test kit for the determination of the concentration of the cancer antigen 125 (CA125) in human serum or plasma. Clinically, it is primarily used as a supportive diagnostic tool and to monitor the treatment of ovarian cancer and other types of cancer. Professional use only; The quantitative test kit for the determination of the concentration of the cancer antigen 15-3 (CA15-3) in human serum equivalent. Clinically, it is primarily used to monitor the response to treatment and prognosis of breast cancer. Professional use only; The quantitative test kit for the determination of the concentration of the cancer antigen 15-3 (CA15-3) in human serum equivalent. Clinically, it is primarily used to monitor the response to treatment and prognosis of breast cancer. Professional use only; The quantitative test kit for the determination of the concentration of the carbohydrate antigen 19-9 (CA19-9) in human serum or plasma in vitro. Clinically, it is primarily used as a supportive diagnostic tool and to monitor the treatment of cancer of the digestive tract, such as the pancreas
- Registration Date
- Jan 24, 2024
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Access comprehensive regulatory information for IVD Cancer Marker Cluster 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 240000196/PCBB-HN and manufactured by Nanjing Norman Biological techlonogy Co., Ltd. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT THIẾT BỊ THIÊN PHÚC.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Theo theo phụ lục, NANJING NORMAN BIOLOGICAL TECHNOLOGY CO., LTD., and 2 recent registrations in the same category. 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.