HbA1c Test Kit Afinion
HbA1c Dx HbA1c Test 15 Tests CLIA Non-Waived
Abbott 1116794

HbA1c Test Kit Afinion
HbA1c Dx HbA1c Test 15 Tests CLIA Non-Waived
Abbott 1116794

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

Manufacturer # 1116794 Brand Afinion™ HbA1c Dx Manufacturer Abbott Rapid Dx North America LLC Country of Origin Norway Application HbA1c Test Kit Buy American Act (BAA) Compliant No CLIA Classification CLIA Moderate Complexity CLIA Classified CLIA Non-Waived Contents 1 (15) HbA1c Dx (Diagnosis) Test Cartridges For Use With For Afinion™ 2 Analyzer Is_ECAT N Is_GSA Y Is_VA N Number of Tests 15 Tests Purchase Program Type Standard Purchase Reading Type Machine Read Sample Type Whole Blood Sample Specialty Chemistry Storage Requirements Requires Refrigeration Test Format Cartridge Format Test Kit Type Rapid Test Name HbA1c Test Test Type Diabetes Management Time to Results 3 Minute Results Trade Agreement Act (TAA) Compliant Yes UNSPSC Code 41116104