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BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Class B IVD
Bio-Rad Laboratories, Inc.
The VARIANT™ II TURBO HbA1c Kit - 2.0 is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood using ion-exchange high-performance liquid chromatography (HPLC) on the VARIANT II TURBO Hemoglobin Testing System and VARIANT II TURBO Link Hemoglobin Testing System. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. Measurement of hemoglobin A1c is effective in monitoring long‑term glycemic control in individuals with diabetes mellitus. The VARIANT II TURBO HbA1c Kit - 2.0 is intended for Professional Use Only. The Hemoglobin Capillary Collection System (HCCS) is intended for the collection of human whole blood for the percent determination of hemoglobin A1c using Bio-Rad HPLC methods.
Models: Wash/Diluent Solution Set - 2702730, Whole Blood Primer - 2700351, Whole Blood Primer - 2700352, Variant II Turbo HbA1c kit 2.0 Prefilter - 2702464, VARIANT II Turbo Hemoglobin Testing system w/o computer - 2702601, Variant II Turbo Hemoglobin Testing system w computer - 2702600, Hemoglobin Capillary Collection System (HCCS) (5 Tests) - 196-2051, Hemoglobin Capillary Collection System (HCCS) (100 Tests) - 196-2052, Hemoglobin Capillary Collection System (HCCS) (5000 Tests) - 196-2053, Variant II Turbo HbA1c Kit 2.0 - 12000447, CDM software image - 12010508