(15) Individually Wrapped Test Cartridges with Desiccant Bag
Contents 1
Package Insert
For Use With
For use with Afinion™ 2 and Alere Afinion™ AS100 Analyzer
Number of Tests
15 Tests
Purchase Program Type
Machine Read
Reading Type
Whole Blood Sample
Sample Type
Requires Refrigeration
Specialty
Cartridge Format
Storage Requirements
HbA1c Test
Test Format
Diabetes Management
Test Kit Type
3 Minute Results
Test Name
41116104
Test Type
Time to Results
UNSPSC Code
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
TEST KIT, HEMOGLOBIN A1C DX MOD COMPLEX (15TST/BX)