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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
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:

Letter (PDF), (Text)

Label (PDF)

Summary (PDF)


Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002