Norovirus GI/GII Positive Control 6 X 0.5 mL
Old Part Number: MDZ049
European Mark of Conformity.
NATtrol Norovirus GI/GII Positive Control is a US FDA Class 1 device, 501(K) exempt, in vitro diagnostic external run control (unassayed) intended for professional use only. This product is not intended for use as a substitute for internal controls provided by in vitro diagnostic kit manufacturers. Quality control materials should be used in accordance with local, state, federal, and accreditation requirements. Propagation or commercialization are prohibited without prior written consent from Antylia Scientific.
When used as a control for nucleic acid tests, the same protocols as those used to amplify extracted clinical specimens should be employed.
The suitability and performance characteristics should be determined by your laboratory for each intended usage.
NATtrol™ Norovirus GI/GII Positive Control (NATNOV-6MC-IVD) is an in vitro diagnostic external run control intended for use in evaluating and monitoring of qualitative molecular diagnostic assays for the detection of Norovirus GI/GII nucleic acid. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic error.
The NATtrol™ Norovirus GI/GII Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens.