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