AUDIT MicroControls Inc, Carlsbad, Calif has received FDA 510(k) approval of Vitamin D as an addition to its complete line of calibration verification/linearity and daily quality control products.
The serum-based Vitamin D Linearity & Control Kits will be available in fall 2013.
The Vitamin D Linearity will have five levels, and the control will have 2 levels.
This liquid product, when stored at 2° to 8°C, has a shelf life of 2 years and an open-vial stability of 14 days for linearity and 30 days for the control.
The company provides a free, online, real-time data-reduction program that offers Levy-Jennings charts and peer-group analysis for daily quality control product users, as well as linearity graphs and peer group analysis. The Audit® FaxBack™ option returns results in 1 business day.
[Source: AUDIT MicroControls]