© Copyright 2017 Qualicon Diagnostics LLC, a Hygiena™ Company or its affiliates. All rights reserved worldwide. No part of this
publication may be reproduced or transmitted in any form, or by any information storage and retrieval system, without the prior
agreement and written permission of Hygiena.
Information in this document is subject to change without notice. Hygiena assumes no responsibility for any errors that may appear in
this document. This document is believed to be complete and accurate at the time of publication. In no event shall Hygiena be liable
for incidental, special, multiple, or consequential damages in connection with or arising from the use of this document.
Part Number: UG-002 Rev 01 v1.3
Effective Date: 29 AUG 2017
TRADEMARKS
The Hygiena™ logo and BAX® are trademarks or registered trademarks of Hygiena or its affiliates. SYBR is a registered trademark
of Thermo Fisher Scientific or its subsidiaries in the U.S. and/or certain other countries. MATLAB is a registered trademark of The
Mathworks, Inc. Microsoft Windows® is a registered trademark of Microsoft Corporation. All other trademarks are property of their
holders.
FIELD OF USE
Data obtained from the BAX® System should not be used for human diagnostic or human treatment purposes. Equipment is not
approved by the United States Food and Drug Administration or any other U.S or non-U.S. regulatory agency for use in human
diagnostics or treatment. The BAX® System should not be used as the sole basis for assessing the safety of products for release to
consumers. The information generated is only to be used in conjunction with the user’s regular quality assurance program. Use for
research and development, quality assurance and quality control under supervision of technically qualified persons. Read the
Limitation of Warranty and Liability before using product.
LICENSING
MATHWORKS
MATLAB 1984-2005 The MathWorks, Inc. is deployed with the BAX® System application and governed by a certain license agreement
between Hygiena and MathWorks. License agreement files (MathWorks or Third-Party) that are included with the MCR Libraries
(“MCR Library License”) may not be modified or removed.
THERMO FISHER SCIENTIFIC
The SYBR® Green I stain in some BAX® System PCR assays is sold under license from Life Technologies Corporation, a Thermo
Fisher Scientific Company, for use only in homogenous polymerase chain reaction assays in combination with the DNA detection
technology of Hygiena, and is covered by pending and issued patents.
PROMEGA CORPORATION
GoTaq® Hot Start Polymerase in some BAX® System PCR assays is sold under distribution agreement with Promega Corporation.
GoTaq® Hot Start Polymerase is manufactured by and licensed to Promega Corporation under U.S. Patent Nos. 5,338,671 and
5,587,287 and their corresponding foreign patents and sold to Hygiena for distribution.
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