Total T4: Quantitative Testing - Vietnam Registration 240000814/PCBB-HN
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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Device Details
Registration Details
240000814/PCBB-HN
000.00.19.H26-240410-0018
Theo theo phụ lục
Theo phụ lục
Technical Details
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
Apr 19, 2024