Vietnam MOH registration 240000712/PCBB-HCM

IVD Department quantitative antibody test for Thyroglobulin

VN: Bộ IVD xét nghiệm định lượng kháng thể kháng Thyroglobulin

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Beckman Coulter, Inc.·Registered Apr 04, 2024

Registration details

Analysis ID: 240000712/PCBB-HCM
Submission ID: 000.00.19.H29-240111-0029
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

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

Technical details

Intended Use: 1/ The quantitative antibody test for Thyroglobulin (Type: ACCESS THYROGLOBULIN ANTIBODY II / Product Code: C86552): It is a fluorescent chemiluminescence, particle-enhanced immunoassay for the quantitative determination of thyroglobulin antibodies in human serum and plasma using the Access Immunoassay Systems. The measured value of the thyroglobulin autoantibody can support the diagnosis of Hashimoto's disease, non-toxic goiter, and Graves' disease. 2/ The quantitative antibody test for Thyroglobulin (Type: ACCESS THYROGLOBULIN ANTIBODY II CALIBRATORS / Product Code: A36920): It is used to calibrate the Access Thyroglobulin II antibody test for the quantitative determination of thyroglobulin antibodies in human serum and plasma using the Access Immunoassay Systems.

Dates and status

Registration Date: Apr 04, 2024

About this record

Access comprehensive regulatory information for IVD Department quantitative antibody test for Thyroglobulin 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 240000712/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.

This page provides complete technical specifications, regulatory compliance details. 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.