Description
Abbott Safety-Data-Sheet-Exemption
Afinion_Alere Safety DATA sheet
Unit: 1 Box
Regulatory Status: Moderately Complex / Professional Use Only
Contents: 15 Test cartridges packed separately in foil pouches with a desiccant bag, 1 Package insert
Determinations: ACR (albumin, creatinine and albumin/creatinine ratio)
Storage Requirements: Refrigerated storage 36-46°F- until expiration date
Sample Volume: 3.5 µL human urine
Processing Time: 5 minutes
The Afinion™ ACR (albumin, creatinine and albumin/creatinine ratio) detects microalbuminuria in human urine. Microalbuminuria is the first clinical sign of diabetic renal disease and cardiovascular disease. Simple testing for microalbuminuria is extremely efficient as an early indicator of renal failure.
Features:
- Compact, rapid, multi-assay analyzer provides valuable near patient testing at the point-of-care
- Fast and easy test for quantitative determinations of HbA1c and ACR
- On-the-spot testing, regardless of sample type (whole blood or urine) delivers accurate results for improved patient management
- Moderately Complex ACR Results in less than 5 minutes
- Good correlation to laboratory methods and POC method
- Measuring range: Albumin:5.0 – 200.0 mg/L
- Measuring range: Creatinine: 16.4 – 339.9 mg/dL (1.5 – 30.0 mmol/L)
- Measuring range: ACR: 1.0 – 1225.0 mg/g (0.1 – 140.0 mg/mmol)
