Ortho-Clinical VITROS Immunodiagnostic Products B•R•A•H•M•S PCT Reagent Pack
- Registration number
- DE0506202
- Model name
- VITROS Immunodiagnostic Products B•R•A•H•M•S PCT Reagent Pack; VITROS Immunodiagnostic Products B•R•A•H•M•S PCT Calibrators; VITROS Immunodiagnostic Products B•R•A•H•M•S PCT Controls
- Model identifier
- 6905558; 6905559; 6905560
- Registration date
- September 23, 2021
- Source update date
- March 29, 2022
- Risk class
- Class C
- Product owner
- Ortho-Clinical Diagnostics
- Registrant / registration holder
- ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
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.
- Product owner address
- Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, United Kingdom
- Registrant address
- 1 INTERNATIONAL BUSINESS PARK, #01-12, THE SYNERGY, Singapore 609917
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.