The CliniMACS Formulation Unit is a MACS GMP Instrument. MACS GMP Instruments are for research use and
ex vivo
cell culture processing only, and are not intended for human
in vivo
applications. They are intended to be
used as manufacturing equipment for cell-based medicinal products. MACS GMP Instruments are manufactured
and tested under a quality management system (ISO 13485) and are in compliance with relevant GMP guidelines.
CAUTION: Clinical Research System. Limited by Federal (or United States) Law to Investigational Use or under an
FDA Approval. In the USA, products of the CliniMACS Product Line are available for use only under an approved
Investigational New Drug (IND) application or Investigational Device Exemption (IDE).
Unless otherwise specifically indicated, Miltenyi Biotec products and services are for research use only and not for
therapeutic or diagnostic use.
Copyright © 2022 Miltenyi Biotec and/or its affiliates. All rights reserved.
No part of this publication may be reproduced, stored in a retrieval system, transmitted, published, or distributed in
any form or by any means, electronically, mechanically, by photocopying, microfilming, recording, or otherwise,
without the prior written consent of Miltenyi Biotec; however, notwithstanding the foregoing, the owners of the
CliniMACS Prodigy System may make copies solely for purposes of training personnel in the use and servicing of the
unit within their business or organization.
CliniMACS, CliniMACS Prodigy, MACS, and the Miltenyi Biotec logo are registered trademarks or trademarks of Miltenyi
Biotec B.V. & Co. KG and/or its affiliates in various countries worldwide. All other trademarks mentioned in this
document are the property of their respective owners and are used for identification purposes only.
