IVD Department quantitative Thyroglobulin test
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Oct 21, 2022- Analysis ID
- 220003339/PCBB-HCM
- Submission ID
- 000.00.19.H29-221017-0026
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Theo theo phụ lục
- Manufacturer Country
- Theo theo phụ lục
- Intended Use
- Access Thyroglobulin Test (Type: Access Thyroglobulin): Access Thyroglobulin Test is a fluorescent, flow cytometric immunoassay for the quantitative determination of thyroglobulin in human serum and plasma by the Access Immunoassay Systems. The device is intended to support the monitoring of the presence of localized and metastatic thyroid tissue in patients who have undergone thyroidectomy (with or without radiation) and in individuals who are deficient in thyroglobulin antibodies in their serum. Access Thyroglobulin Quantitative Test Calibration Standards (Type: Access Thyroglobulin Calibrators): Access Thyroglobulin Calibration Standards are used to calibrate the Access Thyroglobulin Test for the quantitative determination of thyroglobulin in human serum and plasma by the Access Immunoassay Systems.
- Registration Date
- Oct 21, 2022
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Access comprehensive regulatory information for IVD Department quantitative Thyroglobulin test 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 220003339/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.