Australia - English - Department of Health (Therapeutic Goods Administration)

surgical specialties pty ltd -

Singapore - English - HSA (Health Sciences Authority)

radiometer s.e.a. pte. ltd. - hematology - the hemocue® hb 201+ system is intended for quantitative determination of hemoglobin in capillary, venous or arterial whole blood using a specially designed analyzer, the hemocue hb 201+ analyzer, and specially designed microcuvettes, the hemocue hb 201 microcuvettes. hemocue hb 201 microcuvettes are for in vitro diagnostic use only. the hemocue hb 201+ analyzer is only to be used with hemocue hb 201 microcuvettes. the hemocue hb 201+ system is an automated system for professional use, intended for near-patient (point-of-care) and laboratory testing. indications for use is quantitative determination of hemoglobin to support clinical decisions in the detection of anemias, erythrocytosis and polycythemias.

Singapore - English - HSA (Health Sciences Authority)

radiometer s.e.a. pte. ltd. - hematology - the hemocue plasma/low hb system is intended for quantitative determination of low levels of hemoglobin in plasma and serum specimens, aqueous solutions, or supernatant from erythrocyte suspensions using a specially designed photometer, the hemocue plasma/low hb photometer and specially designed microcuvettes, the hemocue plasma/low hb microcuvettes. the hemocue plasma/low hb system is an automated system intended for clinical laboratory testing by healthcare professionals and laboratory personnel. the hemocue plasma/low hb system is for in vitro diagnostic use only. the hemocue plasma/low hb photometer is only to be used with hemocue plasma/low hb microcuvettes.

Singapore - English - HSA (Health Sciences Authority)

radiometer s.e.a. pte. ltd. - gastroenterology & urology - the quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the hemocue albumin analyzer. the system can be used for quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. hemocue urine albumin microcuvettes are for in vitro diagnostic use only. the hemocue albumin analyzers are only to be used with hemocue urine albumin microcuvettes.

Singapore - English - HSA (Health Sciences Authority)

radiometer s.e.a. pte. ltd. - hematology - the hemocue hb 201 dm system is an automated system for professional use, intended for near-patient (point-of-care) and laboratory testing. indications for use is quantitative determination of hemoglobin to support clinical decisions in the detection of anemias, erythrocytosis and polycythemias.

Singapore - English - HSA (Health Sciences Authority)

radiometer s.e.a. pte. ltd. - hematology - the hemocue wbc system is intended for quantitative determination of white blood cell (wbc) count in capillary or venous whole blood, as an aid in the detection or monitoring of leukopenia or leukocytosis. the hemocue wbc system is intended to be used for adults and children above 1 month old. the hemocue wbc system is for in vitro diagnostic use only. the hemocue wbc system is an automated system for use by healthcare professionals and laboratory personnel, intended for near-patient (point-of-care) and clinical laboratory testing. the hemocue wbc analyzer is only to be used with hemocue wbc microcuvettes.

Singapore - English - HSA (Health Sciences Authority)

radiometer s.e.a. pte. ltd. - hematology - the hemocue hb 301 system is intended for quantitative near-patient (point-of-care) whole blood hemoglobin determination in primary care or blood donation settings using a specially designed analyzer, the hemocue hb 301 analyzer, and specially designed microcuvettes, the hemocue hb 301 microcuvettes. the hemocue hb 301 system is for in vitro diagnostic use only. the hemocue hb 301 analyzer is only to be used with hemocue hb 301 microcuvettes. the hemocue hb 301 system is an automated system for professional use by laboratory personnel and healthcare professionals. indications for use is quantitative determination of hemoglobin to support clinical decisions in the detection of anemias, erythrocytosis and polycythemias.

Singapore - English - HSA (Health Sciences Authority)

radiometer s.e.a. pte. ltd. - hematology - the hemocue hba1c 501 system is a point of care device which provides a convenient method for measuring the percentage of haemoglobin a1c (hba1c %) in both capillary and anticoagulated venous whole blood samples. the hemocue hba1c 501 system is intended to be used by professionals in laboratories, clinics and hospitals.

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

radiometer medical aps, denmark - clinical chemistry analyser and consumables -

Singapore - English - HSA (Health Sciences Authority)

radiometer s.e.a. pte. ltd. - hematology - the hemocue hb 801 system is intended for the quantitative determination of hemoglobin in capillary or venous whole blood in near-patient (point-of-care) and blood donation settings, including primary care, hospital settings and road ambulance setting. the hemocue hb 801 system is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old. the hemocue hb 801 system is an automated system for professional in vitro diagnostics use by laboratory personnel and healthcare professionals. indications for use is quantitative determination of hemoglobin to support clinical decisions in the detection of anemias, erythrocytosis and polycythemias.