Intended use
The AltoStar® CMV PCR Kit 1.5 CAN is an in vitro diagnostic test, based on real-time PCR technology, for thequantification of human cytomegalovirus (CMV) specific DNA in human EDTA plasma.
The AltoStar® CMV PCR Kit 1.5 CAN is intended to be used for the management of CMV infection in patients at risk for CMV disease. It is not intended for use as screening test for the presence of CMV in blood or blood products or as a diagnostic test to confirm the presence of CMV infection.
LoD EDTA plasma 215 IU/ml
The following sample types are validated for use with the AltoStar® CMV PCR Kit 1.5 CAN:
Human EDTA plasma
The AltoStar® CMV PCR Kit 1.5 CAN is configured for use with CFX96™ Deep Well Dx System (Bio-Rad) in combination with the AltoStar® Automation System AM16, the AltoStar® Purification Kit 1.5 and the AltoStar® Internal Control 1.5.
Products not FDA cleared or approved. Kits not available in all countries.
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altona Diagnostics GmbH
Mörkenstr. 12
22767 Hamburg, Germany
altona Diagnostics GmbH
Mörkenstr. 12
22767 Hamburg, Germany
