IVD Department Quantitative SHBG Testing
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Sep 28, 2022- Analysis ID
- 220003107/PCBB-HCM
- Submission ID
- 000.00.19.H29-220921-0037
- 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. SHBG Quantitative Assay (Type: Access SHBG): It is a fluorescent immunoassay, based on the principle of chemiluminescence, for the quantitative determination of sex hormone-binding globulin in human serum and plasma by the Access Immunoassay Systems. 2. SHBG Quantitative Assay Calibration Standards (Type: Access SHBG Calibrators): These are used to calibrate the Access SHBG quantitative assay to determine the concentration of sex hormone-binding globulin in human serum and plasma by the Access Immunoassay Systems. 3. SHBG Quantitative Assay Control Material (Type: Access SHBG QC): It is used to monitor the performance of the Access SHBG quantitative assay in the system.
- Registration Date
- Sep 28, 2022
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Access comprehensive regulatory information for IVD Department Quantitative SHBG Testing 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 220003107/PCBB-HCM and manufactured by Theo theo phụ lục.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Theo theo phụ lục, Beckman Coulter, Inc., 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.