Search Results
Found 1 results
510(k) Data Aggregation
(179 days)
The Nova Allegro urine albumin creatinine ratio (UACR) assay is intended for the quantitative determination of albumin, creatinine, and the albumin/creatinine ratio (UACR) in human urine. The measurement of urine albumin, creatinine, and albumin/creatinine ratio aids in the early diagnosis of nephropathy.
The Nova Allegro Analyzer is intended for in vitro diagnostic use in clinical laboratory and near-patient testing (point-of-care) settings for the quantitative determination of Nova Allegro Assays using Nova Allegro Test Cartridges.
Nova Allegro UACR Assay
The Nova Allegro UACR Assay is a completely automated assay that functions with the Nova Allegro Analyzer for the determination of albumin and creatinine and the calculation of UACR in human urine. The Nova Allegro UACR Assays are performed sequentially using a single Allegro UACR test cartridge. The Allegro UACR Test Cartridge contains all of the reagents for measuring albumin and creatinine. Allegro UACR Controls are used to monitor the performance of the Nova Allegro UACR Test Cartridge and Allegro analyzer.
Nova Allegro Analyzer
The Nova Allegro Analyzer is a compact, point-of-care analyzer that features a clinically important menu of measured and calculated tests. All tests are measured with disposable, ready-to-use cartridges. The analyzer supports multiple wavelengths that are used to measure the assay of interest. The analyzer consists of the following key systems/components that the user interacts with:
- Two analytical bays where the single use test cartridges are analyzed
- Color Touchscreen Display
- Barcode Scanner
- Printer
- Data Export Options
- Ethernet Connection
- USB Port
N/A
Ask a specific question about this device
Page 1 of 1