IVD Department, Total T3 Quantitative Testing - Vietnam Registration 240000053/PCBB-BYT
Access comprehensive regulatory information for IVD Department, Total T3 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 240000053/PCBB-BYT and manufactured by Ortho-Clinical Diagnostics. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.
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.
Device Details
Registration Details
240000053/PCBB-BYT
000.00.04.G18-240326-0005
Theo theo phụ lục
Theo phụ lục
Technical Details
The IVD Quantitative Total T3 Assay Kit consists of the following components: (1) VITROS Immunodiagnostic Products Total T3 Reagent Pack: For in vitro diagnostic quantitative determination of total triiodothyronine (T3) in human serum and plasma (EDTA or heparin) on the VITROS ECi/ECiQ/3600 and VITROS 5600/XT 7600 Immunoassay Systems, to aid in the differential diagnosis of thyroid disorders. (2) VITROS Immunodiagnostic Products Total T3 Calibrators: For in vitro diagnostic calibration of the VITROS ECi/ECiQ/3600 and VITROS 5600/XT 7600 Immunoassay Systems when quantitating total triiodothyronine (T3) in human serum and plasma (EDTA or heparin).
Dates and Status
Apr 04, 2024