Vietnam MOH registration 240000814/PCBB-HN

Total T4: Quantitative Testing

VN: Bộ IVD xét nghiệm định lượng T4 tổng số

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Ortho-Clinical Diagnostics·Registered Apr 19, 2024

Registration details

Analysis ID: 240000814/PCBB-HN
Submission ID: 000.00.19.H26-240410-0018
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Ortho-Clinical Diagnostics
Manufacturer Country: Theo theo phụ lục
Product Owner: Ortho-Clinical Diagnostics
Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM

Technical details

Intended Use: The IVD Quantitative Total T4 Assay Kit consists of the following components: (1) VITROS Immunodiagnostic Products Total T4 Reagent Pack: For in vitro diagnostic quantitative determination of total thyroxine (T4) in human serum and plasma (EDTA or heparin) on the VITROS ECi/ECiQ/3600 and VITROS Integrated 5600/XT 7600 Systems to aid in the differential diagnosis of thyroid disorders. (2) VITROS Immunodiagnostic Products Total T4 Calibrators: For in vitro diagnostic calibration of the VITROS ECi/ECiQ/3600 and VITROS Integrated 5600/XT 7600 Systems when quantitating total thyroxine (T4) in human serum and plasma (EDTA or heparin).

Dates and status

Registration Date: Apr 19, 2024

About this record

Access comprehensive regulatory information for Total T4: Quantitative 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 240000814/PCBB-HN and manufactured by Ortho-Clinical Diagnostics. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.

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