Vietnam MOH registration 240001750/PCBB-HN

IVD Department Quantitative Cortisol Testing

VN: Bộ IVD xét nghiệm định lượng Cortisol

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Ortho-Clinical Diagnostics·Registered Jul 22, 2024

Registration details

Analysis ID: 240001750/PCBB-HN
Submission ID: 000.00.19.H26-240716-0022
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 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

Registration Date: Jul 22, 2024

About this record

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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