IVD Quantitative Inhibin A Test Kit
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Theo theo phụ lục·Registered Apr 18, 2023- Analysis ID
- 2300241ĐKLH/BYT-TB-CT
- Submission ID
- 19010501/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Theo theo phụ lục
- Manufacturer Country
- Theo theo phụ lục
- Intended Use
- 1. Inhibin A Quantitative Assay (Type: Access Inhibin A): It is a fluorescent immunoassay, based on the principle of chemiluminescence, to quantitate the level of inhibin A dimers in human serum and plasma (heparin and EDTA) to support the diagnosis and monitoring of different types of reproductive hormone disorders by using the Access Immunoassay Systems. 2. Inhibin A Quantitative Assay Calibration Standards (Type: Access Inhibin A Calibrators): Used to calibrate the Access Inhibin A Assay to quantitate the levels of inhibin A dimers in human serum and plasma (heparin and EDTA) by using the Access Immunoassay Systems. 3. Inhibin A Quantitative Assay Quality Control Materials (Type: Access Inhibin A QC): Used to monitor the performance of the Access Inhibin A Assay of the system.
- Registration Date
- Apr 18, 2023
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