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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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1998 Biological Device Application Supplement Approvals

This list reflects information regarding the supplements as of the approval date; it is not updated with regard to applicant or application status changes. The supplements are listed in order by date of approval.


Tradename Description and Indication for Device Applicant Number Approval Date
CEPRATE SC Stem Cell Concentration System New Indication:
For processing of peripheral blood progenitor cells to obtain a CD34+ cell enriched population which is intended for hematopoietic support after myeloablative chemotherapy in patients with CD34-negative tumors
CellPro, Inc
22215 26th Avenue SE
Bothell, WA 98021
BP940001-03 7/27/1998
Home Access HIV-1 Test System Change to Clienttrak software to allow processing of samples during 10-day period after kit expiration Home Access Health Corp
Hoffman Estates, IL 60195-5200
BP950002-05 8/14/1998
Abbott Corzyme-M (rDNA) New Indication:
Diagnostic enzyme immunoassay kit for quantitative determination of specified antibody IgM anti-HBc in human serum or plasma for use as an aid in the diagnosis of acute or recent hepatitis B viral infection
Abbott Laboratories
100 Abbott Park Rd
Abbott Park, IL 60064-3500
BP830014-01 12/31/1998