IVD Department quantitative Procalcitonin testing
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Ortho-Clinical Diagnostics·Registered Apr 19, 2024- Analysis ID
- 240000813/PCBB-HN
- Submission ID
- 000.00.19.H26-240410-0020
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- 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
- Intended Use
- The IVD Quantitative Procalcitonin Assay Kit comprises the following components: (1) The quantitative Procalcitonin (PCT) test reagent (VITROS Immunodiagnostic Products BRAHMS PCT Reagent Pack): For in vitro diagnostic use to quantitate procalcitonin (PCT) in human serum and plasma (lithium heparin and EDTA) on the VITROS ECi/ECiQ/3600 and Integrated VITROS 5600/XT 7600 systems. The BRAHMS PCT test is indicated for use in combination with clinical judgment to aid in the diagnosis of: •early and clinically distinct cases of infection, •the severity and prognosis of systemic infection, sepsis, severe sepsis, and septic shock, •determining the response to antibiotic therapy, •monitoring the course of antibiotic therapy within the range of measurement, •assessing the success of antibiotic therapy in suspected or confirmed cases of infection. (2) The quantitative Procalcitonin (PCT) test calibrators (VITROS Immunodiagnostic Products BRAHMS PCT Calibrators): For in vitro diagnostic use to calibrate the VITROS ECi/ECiQ/3600 and Integrated VITROS 5600/XT 7600 systems when quantitating procalcitonin (PCT) in human serum and plasma (lithium heparin and EDTA). (3) The quantitative Procalcitonin (PCT) test controls (VITROS Immunodiagnostic Products BRAHMS PCT Controls): For in vitro diagnostic use to monitor the performance of the VITROS ECi/ECiQ/3600 and Integrated VITROS 5600/XT 7600 systems when quantitating procalcitonin (PCT).
- Registration Date
- Apr 19, 2024
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Access comprehensive regulatory information for IVD Department quantitative Procalcitonin 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 240000813/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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