Singapore HSA registration DE0506202
Ortho-Clinical VITROS Immunodiagnostic Products B•R•A•H•M•S PCT Reagent Pack
Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0506202
- Registration Date
- September 23, 2021
- Change Notification Approval Date
- March 29, 2022
- Retention Due Date
- September 22, 2025
Product description
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
- Short Name
- Ortho-Clinical Diagnostics
- Address
- Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, UNITED KINGDOM
Registrant
- Address
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Importer
- Address
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model information
- Model Name(s)
- 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(s)
- 6905558 6905559 6905560
About this record
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.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD