Abbott Rapid Dx North America LLC HbA1c Test Kit Afinion™ HbA1c Dx Diabetes Management HbA1c Test...
| Item Id | 1154497 |
| MF Id# | 1116794 |
| Brand | Afinion™ HbA1c Dx |
| Manufacturer | Abbott Rapid Dx North America LLC |
| Country of Origin | Norway |
| Application | HbA1c Test Kit |
| CLIA Classification | CLIA Moderate Complexity |
| CLIA Classified | CLIA Non-Waived |
| Contents 1 | (15) Individually Wrapped Test Cartridges with Desiccant Bag, Package Insert |
| For Use With | For use with Afinion™ 2 and Alere Afinion™ AS100 Analyzer |
| 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 Name | HbA1c Test |
| Test Type | Diabetes Management |
| Time to Results | 3 Minute Results |
| UNSPSC Code | 41116104 |
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

