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Vaccines, Blood & Biologics
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
Label (PDF)
Summary (PDF)
Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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