The Clinimacs Formulation Unit; Regulatory Information; Intended Use - Miltenyi Biotec CliniMACS Formulation Unit User Manual

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The CliniMACS Formulation Unit

4.1 Regulatory information

The CliniMACS Prodigy Cell & Gene Therapy Manufacturing System is intended
for genetic and/or other substantial manipulation (like transfection,
proliferation, differentiation) steps of human cells.
 CliniMACS Prodigy is no medical device in Europe if used as part of the
CliniMACS Prodigy Cell & Gene Therapy Manufacturing System.
 For U.S. CAUTION: Clinical Research System. Limited by Federal (or United
States) Law to Investigational Use or under an FDA Approval.
For regulatory status in countries outside Europe, contact the authorized local
Miltenyi Biotec Service Provider.

4.1.1 Intended use

The CliniMACS Formulation Unit is an equipment intended to enable the in vitro
final formulation and sampling of cell populations for clinical applications in
combination with the CliniMACS Prodigy only.
The CliniMACS Formulation Unit is for research use and in vitro cell culture pro ces -
sing only. It is intended to be used by professional users in a GMP environment.
The CliniMACS Formulation Unit is intended to be used as manufacturing
equipment for cell-based medicinal products, e.g., in applications of the
CliniMACS Prodigy Cell & Gene Therapy Manufacturing System. The CliniMACS
Formulation Unit is not intended to be used within Medical Device applications
of the CliniMACS Prodigy Cell Separation System.
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