IVD Quantitative Inhibin A Test Kit - Vietnam Registration 2300241ĐKLH/BYT-TB-CT
Access comprehensive regulatory information for IVD Quantitative Inhibin A Test Kit in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2300241ĐKLH/BYT-TB-CT and manufactured by Theo theo phụ lục.
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Device Details
Registration Details
2300241ĐKLH/BYT-TB-CT
19010501/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
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.
Dates and Status
Apr 18, 2023