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HSA · registration DE0506202

Ortho-Clinical VITROS Immunodiagnostic Products B•R•A•H•M•S PCT Reagent Pack

SingaporeClinical chemistryClass COrtho-Clinical Diagnostics
Official record identity
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
Classification
Risk class
Class C
Official value: CLASS C
Published category
Clinical chemistry
Published parties
Official 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.

Additional source fields
Product owner address
Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, United Kingdom
Registrant address
1 INTERNATIONAL BUSINESS PARK, #01-12, THE SYNERGY, Singapore 609917
About this record

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.