1998 Biological Device Application Supplement Approvals for New Indications
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 |