HbA1c Test Kit Afinion™ HbA1c Dx HbA1c Test 15 Tests CLIA Non-Waived

Features

• Afinion™ HbA1c Dx is categorized as MODERATE COMPLEXITY under the Clinical Laboratory Improvement Amendment of 1988 (CLIA’88)
• Afinion HbA1c Dx is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human venous and capillary whole blood
• The Afinion™ HbA1c Dx Test Cartridge contains all reagents necessary for the measurement of glycated hemoglobin with 3 months room temperature storage
• The test cartridge should be used within 10 minutes after opening
• The test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes