2000 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 |
|---|---|---|---|---|
| Home Access HIV-1 Test System | HIV Testing Service to be used with the Organon Teknika Vironostika HIV-1 Microelisa System | Home Access Health Corp 2401 West Hassell Rd Suite 1510 Hoffman Estates, IL 60195-5200 |
BP950002-02 | 3/15/2000 |
| Roche Amplicor HIV-1 Monitor Test | In vitro test for the quantitation of HIV-1 RNA in human plasma | Roche Molecular System, Inc 4300 Hacienda Dr P.O. Box 9002 Pleasanton, CA 94566-0990 |
BP950005-01 | 4/10/2000 |