Ortho-Clinical VITROS Immunodiagnostic Products B•R•A•H•M•S PCT Reagent Pack - HSA Registration DE0506202
Access comprehensive regulatory information for Ortho-Clinical VITROS Immunodiagnostic Products B•R•A•H•M•S PCT Reagent Pack in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0506202 and owned by Ortho-Clinical Diagnostics. The device was registered on September 23, 2021.
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For the quantitative measurement of procalcitonin (PCT) in human serum and plasma (lithium heparin and EDTA) using the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. The VITROS B•R•A•H•M•S PCT test is indicated as an aid to be used in conjunction with clinical evaluation for: • the early detection and differential diagnosis of clinically relevant bacterial infections, • the assessment of the degree of severity and the prognosis of the outcome of systemic bacterial infection, sepsis, severe sepsis and septic shock, • identifying patients that benefit from antibiotic treatment, • monitoring of antibiotic therapy within the measuring range, • the assessment of successful antibiotic therapy in patients with suspected or confirmed bacterial infection.