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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Isolex 300 & 300i Magnetic Cell Selection System

Product: Isolex 300 & 300i Magnetic Cell Selection System
Applicant:
Nexell Therapeutics, Inc., Irvine, CA
PMA number:
BP970001 & BP970001 Supplement 01
Indication for Use:
Processing autologuous peripheral blood progenitor cell (PBPC) products to obtain a CD 34+ cell enriched population intended for hematopoietic reconstitution after myeloablative therapy in patients with CD 34-negative tumors.
Approval Date:
7/2/99


Letter (PDF), (Text)

Label (PDF)

Summary (PDF)

 

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(800) 835-4709
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Food and Drug Administration

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