IVD Department quantitative Thyroglobulin test
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Beckman Coulter, Inc.·Registered Apr 04, 2024- Analysis ID
- 240000711/PCBB-HCM
- Submission ID
- 000.00.19.H29-240111-0028
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Beckman Coulter, Inc.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Beckman Coulter, Inc.
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN BECKMAN COULTER HONG KONG LIMITED TẠI TPHCM
- Intended Use
- 1/ The Thyroglobulin Quantitative Assay (Type: ACCESS THYROGLOBULIN/ Product Code: C71762): It is a fluorescent, chemiluminescent 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 radiotherapy) and in individuals who are deficient in thyroglobulin antibodies in the serum. 2/ The Thyroglobulin Quantitative Assay Calibration Standards (Type: ACCESS THYROGLOBULIN CALIBRATORS/ Product Code: 33865): Used to calibrate the Access Thyroglobulin Assay for the quantitative determination of thyroglobulin in human serum and plasma by the Access Immunoassay Systems.
- Registration Date
- Apr 04, 2024
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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 240000711/PCBB-HCM and manufactured by Beckman Coulter, Inc.. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN BECKMAN COULTER HONG KONG LIMITED TẠI TPHCM.
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