IVD Department Quantitative Cortisol Testing - Vietnam Registration 240001750/PCBB-HN
Access comprehensive regulatory information for IVD Department Quantitative Cortisol 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 240001750/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
240001750/PCBB-HN
000.00.19.H26-240716-0022
Theo theo phụ lục
Theo phụ lục
Technical Details
The IVD Quantitative Cortisol Test Kit consists of the following components with their intended uses: (1) Quantitative Cortisol Test Reagent Pack (VITROS Immunodiagnostic Products Cortisol Reagent Pack): For in vitro diagnostic use to quantitate cortisol in serum, plasma (heparin or EDTA) or human urine on the VITROS ECi/ECiQ/3600 and VITROS Integrated 5600/XT 7600 systems. (2) Quantitative Cortisol Test Calibrators (VITROS Immunodiagnostic Products Cortisol Calibrators): For in vitro diagnostic use to calibrate the VITROS ECi/ECiQ/3600 and VITROS Integrated 5600/XT 7600 systems when quantitating cortisol in serum, plasma (heparin or EDTA) or human urine. (3) Quantitative Cortisol Test Metabolism Controls (VITROS Immunodiagnostic Products Metabolism Controls): For in vitro diagnostic use to monitor the performance of the VITROS ECi/ECiQ/3600 and VITROS Integrated 5600/XT 7600 systems when quantitating cortisol in serum, plasma (heparin or EDTA) and human urine.
Dates and Status
Jul 22, 2024